Latest Generic Drug Approvals

First-Time Generics are the very first generic versions of marketed brand-name drug products to be approved by the FDA. The generic version is formulated to work in the same way as the brand-name product and provides the same clinical benefit.

See also: New drug approvals, New drug applications, Generic drugs

First-time generic approvals 2024

April

• Valbenazine Tosylate Capsules 40 mg (base) and 80 mg (base)
  Approved: April 5, 2024 - Lupin Pharmaceuticals, Inc.
  Treatment for: Huntington’s Disease, Tardive Dyskinesia
  Generic for: Ingrezza
• Eribulin Mesylate Intravenous Solution 1 mg/2 mL (0.5 mg/mL)
  Approved: Approved: April 5, 2024 - Gland Pharma Limited
  Treatment for: Breast Cancer, Liposarcoma
  Generic for: Halaven
• Doxycycline (Anhydrous) Immediate/Delayed Release Capsules 40 mg
  Approved: April 8, 2024 - Dr. Reddys Laboratories Inc.; Lupin Pharmaceuticals, Inc.
  Treatment for: Rosacea
  Generic for: Oracea

March

• Finasteride and Tadalafil Capsules 5 mg / 5 mg
  Approved: March 15, 2024 - Zydus Worldwide DMCC
  Treatment for: Benign Prostatic Hyperplasia
  Generic for: Entadfi

February

• Bromfenac Sodium Sesquihydrate Ophthalmic Solution 0.075% (free acid)
  Approved: February 2, 2024 - Lupin Pharmaceuticals, Inc.
  Treatment for: Postoperative Ocular Inflammation
  Generic for: BromSite
• Cobicistat Tablets 150 mg
  Approved: February 7, 2024 - Mylan Pharmaceuticals Inc.
  Treatment for: HIV Infection
  Generic for: Tybost
• Deflazacort Tablets 6 mg, 18 mg, 30 mg and 36 mg
  Approved: February 9, 2024 - Aurobindo Pharma Limited
  Treatment for: Duchenne Muscular Dystrophy
  Generic for: Emflaza
• Ospemifene Tablets 60 mg
  Approved: February 13, 2024 - Hetero Labs Limited
  Treatment for: Menopause Symptoms
  Generic for: Osphena
• Brimonidine Tartrate Ophthalmic Solution 0.025%
  Approved: February 16, 2024 - Dr.Reddy's Laboratories Inc.
  Treatment for: Eye Redness
  Generic for: Lumify
• Nitroglycerin Intra-Anal Ointment 0.4%
  Approved: February 16, 2024 - Cosette Pharmaceuticals, Inc.
  Treatment for: Anal Fissure
  Generic for: Rectiv

January

• Nilotinib Hydrochloride Capsules 50mg (base), 150mg (base) and 200mg (base)
  Approved: January 5, 2024 - Apotex Corp.
  Treatment for: Chronic Myeloid Leukemia
  Generic for: Tasigna
• Fidaxomicin Tablets 200 mg
  Approved: January 16, 2024 - Actavis Laboratories FL, Inc.
  Treatment for: Clostridioides difficile-Associated Diarrhea
  Generic for: Dificid
• Pimavanserin Tartrate Capsules 34 mg (base)
  Approved: January 16, 2024 - MSN Laboratories Private Limited; Zydus Pharmaceuticals USA Inc.
  Treatment for: Parkinson's Disease Psychosis
  Generic for: Nuplazid Capsules
• Pimavanserin Tartrate Tablets 10 mg (base)
  Approved: January 16, 2024 - Zydus Pharmaceuticals USA Inc.
  Treatment for: Parkinson's Disease Psychosis
  Generic for: Nuplazid Tablets
• Dronedarone Hydrochloride Tablets 400 mg (base)
  Approved: January 31, 2024 - Lupin Pharmaceuticals, Inc.
  Treatment for: Atrial Fibrillation
  Generic for: Multaq

December

• Methylene Blue Intravenous Solution 10mg/2mL (5mg/mL) and 50mg/10mL (5mg/mL)
  Approved: December 5, 2023 - Zydus Worldwide DMCC
  Treatment for: Methemoglobinemia
  Generic for: ProvayBlue

November

• Teriparatide Injection 600 mcg/2.4 mL (250 mcg/mL)
  Approved: November 16, 2023 - Apotex Corp.; Teva Pharmaceuticals USA, Inc.
  Treatment for: Osteoporosis
  Generic for: Forteo
• Podofilox Topical Gel 0.5%
  Approved: November 22, 2023 - Padagis US LLC
  Treatment for: Anogenital Warts
  Generic for: Condylox Gel
• Bromfenac Sodium Sesquihydrate Ophthalmic Solution 0.07% (free acid)
  Approved: November 22, 2023 - Lupin Pharmaceuticals, Inc.
  Treatment for: Ocular Inflammation and Pain After Cataract Surgery
  Generic for: Prolensa

October

• Pazopanib Hydrochloride Tablets 200 mg (base)
  Approved: October 19, 2023 - Apotex Corp.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc.
  Treatment for: Renal Cell Carcinoma; Soft Tissue Sarcoma
  Generic for: Votrient

September

• Spironolactone Oral Suspension 25mg/5mL
  Approved: September 5, 2023 - Amneal Pharmaceuticals LLC
  Treatment for: NYHA Class III-IV Heart Failure and Reduced Ejection Fraction
  Generic for: Carospir
• Tofacitinib Citrate Oral Solution 1mg (base)/mL
  Approved: September 25, 2023 - Slayback Pharma LLC
  Treatment for: Polyarticular Course Juvenile Idiopathic Arthritis
  Generic for: Xeljanz Oral Solution

August

• Lifitegrast Ophthalmic Solution 5%
  Approved: August 4, 2023 - Micro Labs Limited
  Treatment for: Dry Eye Disease
  Generic for: Xiidra
• Halobetasol Propionate Aerosol Foam 0.05%
  Approved: August 11, 2023 - Padagis Israel Pharmaceuticals Ltd.
  Treatment for: Plaque Psoriasis
  Generic for: Lexette
• Joyeaux Tablets ethinyl estradiol 0.02 mg / levonorgestrel 0.1 mg with ferrous fumarate 75 mg
  Approved: August 16, 2023 - Xiromed, LLC
  Treatment for: Birth Control
  Generic for: Balcoltra
• Tretinoin Gel (Microsphere) 0.08%
  Approved: August 22, 2023 - Encube Ethicals Private Limited
  Treatment for: Acne Vulgaris
  Generic for: Retin-A Micro 0.08%
• Lisdexamfetamine Dimesylate Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
  Approved: August 25, 2023 - Actavis Elizabeth LLC; Alkem Laboratories Limited; Amneal Pharmaceuticals LLC (excl. 10 mg); Apotex Corp.; Ascent Pharmaceuticals, Inc.; Hikma Pharmaceuticals USA Inc. (excl. 10 mg); Lannett Company, Inc.; Mylan Pharmaceuticals Inc.; Norwich Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Rhodes Pharmaceuticals L.P.; SpecGx LLC; Sun Pharmaceutical Industries, Inc.
  Treatment for: ADHD; Binge Eating Disorder
  Generic for: Vyvanse Capsules
• Lisdexamfetamine Dimesylate Chewable Tablets 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg
  Approved: August 25, 2023 - Ascent Pharmaceuticals, Inc.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc.
  Treatment for: ADHD; Binge Eating Disorder
  Generic for: Vyvanse Chewable Tablets
• Palbociclib Tablets 75mg, 100 mg and 125 mg
  Approved: August 28, 2023 - Synthon Pharmaceuticals, Inc.
  Treatment for: Breast Cancer
  Generic for: Ibrance Tablets

July

• Naltrexone for Extended-Release Injectable Suspension 380 mg/vial
  Approved: July 6, 2023 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Alcohol Dependence; Opioid Dependence
  Generic for: Vivitrol
• Ertugliflozin Tablets 5 mg and 15 mg
  Approved: July 13, 2023 - Aurobindo Pharma Limited
  Treatment for: Type 2 Diabetes
  Generic for: Steglatro
• Ponatinib Hydrochloride Tablets 15 mg (base) and 45 mg (base)
  Approved: July 14, 2023 - ApoPharma USA, Inc.
  Treatment for: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia
  Generic for: Iclusig
• Plerixafor Injection 24 mg/1.2 mL (20 mg/mL)
  Approved: July 24, 2023 - Amneal Pharmaceuticals LLC; Dr. Reddy's Laboratories, Inc.; Eugia Pharma Specialities Limited; Kindos Pharmaceuticals Co. Ltd.; MSN Laboratories Private Ltd.; Teva Pharmaceuticals USA, Inc.
  Treatment for: Peripheral Blood Progenitor Cell Therapy
  Generic for: Mozobil
• Saxagliptin Hydrochloride Tablets 2.5mg (base) and 5 mg (base)
  Approved: July 31, 2023 - Amneal Pharmaceuticals LLC; Aurobindo Pharma Limited; Glenmark Pharmaceuticals Inc.; Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Onglyza
• Saxagliptin Hydrochloride and Metformin Hydrochloride Extended-Release Tablets , 5 mg (base) / 500 mg, 5 mg (base) / 1000 mg, 2.5 mg (base) / 1000 mg
  Approved: July 31, 2023 - Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Kombiglyze XR

June

• Baclofen Oral Suspension 25 mg/5 mL
  Approved: June 8, 2023 - Slayback Pharma LLC
  Treatment for: Spasticity
  Generic for: Fleqsuvy
• Sugammadex Sodium Intravenous Solution 200 mg (base)/2 mL and 500 mg (base)/5 mL
  Approved: June 9, 2023 - Aspiro Pharma Ltd.
  Treatment for: Reversal of Neuromuscular Blockade
  Generic for: Bridion
• Tipiracil Hydrochloride and Trifluridine Tablets 6.14 mg (base)/15 mg and 8.19 mg (base)/20 mg
  Approved: June 13, 2023 - Natco Pharma Ltd.
  Treatment for: Colorectal Cancer/Gastric Cancer
  Generic for: Lonsurf
• Amlodipine Benzoate Oral Suspension 1 mg (base)/mL
  Approved: June 13, 2023 - Amneal Pharmaceuticals LLC
  Treatment for: Hypertension/Coronary Artery Disease
  Generic for: Katerzia
• Safinamide Mesylate Tablets 50mg (base) and 100 mg (base)
  Approved: June 14, 2023 - Aurobindo Pharma Limited
  Treatment for: Parkinson’s Disease
  Generic for: Xadago
• Mometasone Furoate Metered Nasal Spray 0.05 mg/spray (OTC)
  Approved: June 14, 2023 - Amneal Pharmaceuticals LLC
  Treatment for: Allergic Rhinitis
  Generic for: Nasonex 24HR Allergy
• Tiotropium Bromide Inhalation Powder 0.018mg (base) per inhalation
  Approved: June 20, 2023 - Lupin Pharmaceuticals, Inc.
  Treatment for: COPD
  Generic for: Spiriva
• Amphetamine Extended-Release Orally Disintegrating Tablets 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg
  Approved: June 22, 2023 - Actavis Pharma, Inc.
  Treatment for: ADHD
  Generic for: Adzenys XR-ODT
• Alcaftadine Ophthalmic Solution 0.25%
  Approved: June 23, 2023 - Eugia Pharma Specialities Limited
  Treatment for: Allergic Conjunctivitis
  Generic for: Lastacaft
• Cyanocobalamin Metered Nasal Spray 0.5mg/spray
  Approved: June 30, 2023 - Lupin Pharmaceuticals, Inc.
  Treatment for: Vitamin B12 Deficiency
  Generic for: Nascobal

May

• Methsuximide Capsules 300 mg
  Approved: May 1, 2023 - Novitium Pharma LLC
  Treatment for: Seizures
  Generic for: Celontin
• Obeticholic Acid Tablets 5 mg and 10 mg
  Approved: May 30, 2023 - Apotex Corp.; Lupin Pharmaceuticals, Inc.; MSN Laboratories Private Limited
  Treatment for: Primary Biliary Cholangitis
  Generic for: Ocaliva
• Diazepam Rectal Gel 10mg/2mL (5mg/mL) and 20mg/4mL (5mg/mL)
  Approved: May 30, 2023 - Novel Laboratories, Inc.
  Treatment for: Seizures
  Generic for: Diastat AcuDial

April

• Budesonide Rectal Foam 2mg/actuation
  Approved: April 12, 2023 - Padagis Israel Pharmaceuticals Ltd.
  Treatment for: Ulcerative Colitis
  Generic for: Uceris
• Loteprednol Etabonate Ophthalmic Suspension 0.2%
  Approved: April 12, 2023 - Akorn Operating Company LLC
  Treatment for: Seasonal Allergic Conjunctivitis
  Generic for: Alrex
• Estradiol Transdermal System 0.014mg/24hr
  Approved: April 17, 2023 - Zydus Pharmaceuticals USA, Inc.
  Treatment for: Prevention of Postmenopausal Osteoporosis
  Generic for: Menostar
• Thalidomide Capsules 150 mg
  Approved: April 27, 2023 - Natco Pharma Limited
  Treatment for: Multiple Myeloma and Erythema Nodosum Leprosum
  Generic for: Thalomid

March

• Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules 140mg / 125mg / 125mg
  Approved: March 6, 2023 - Par Pharmaceutical Inc.
  Treatment for: Helicobacter Pylori Infection
  Generic for: Pylera
• Betamethasone Dipropionate and Calcipotriene Topical Aerosol Foam 0.064% / 0.005%
  Approved: March 21, 2023 - Glenmark Pharmaceuticals Ltd.
  Treatment for: Plaque Psoriasis
  Generic for: Enstilar
• Tenofovir Alafenamide Fumarate Tablets 25 mg (base)
  Approved: March 30, 2023 - Lupin Pharmaceuticals, Inc.
  Treatment for: Hepatitis B
  Generic for: Vemlidy

February

• Doxepin Hydrochloride Topical Cream 5%
  Approved: February 17, 2023 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Pruritus
  Generic for: Zonalon
• Tiopronin Delayed Release Tablets 100 mg and 300 mg
  Approved: February 24, 2023 - Par Pharmaceutical, Inc.
  Treatment for: Cystinuria
  Generic for: Thiola EC
• Acetaminophen and Ibuprofen Tablets 250 mg / 125 mg
  Approved: February 28, 2023 - L. Perrigo Company
  Treatment for: Pain / Fever
  Generic for: Advil Dual Action with Acetaminophen

December

• Bendamustine Hydrochloride Lyophilized Powder for Injection 25 mg/vial and 100 mg/vial
  Approved: December 7, 2022 - Accord Healthcare Inc.; Dr. Reddys Laboratories Inc.
  Treatment for: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
  Generic for: Treanda
• Tasimelteon Capsules 20 mg
  Approved: December 12, 2022 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Non-24-Hour Sleep Wake Disorder
  Generic for: Hetlioz
• Selexipag Tablets 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg
  Approved: December 21, 2022 - Zydus Pharmaceuticals USA Inc.
  Treatment for:  Pulmonary Arterial Hypertension
  Generic for: Uptravi
• Dichlorphenamide Tablets 50 mg
  Approved: December 29, 2022 - Torrent Pharma Inc.
  Treatment for: Hypokalemic Periodic Paralysis; Hyperkalemic Periodic Paralysis
  Generic for: Keveyis

November

• Penciclovir Cream 1%
  Approved: November 9, 2022 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Cold Sores
  Generic for: Denavir
• Vancomycin Hydrochloride for Oral Solution 25 mg (base)/mL and 50 mg (base)/mL
  Approved: November 14, 2022 - Alkem Laboratories Ltd.
  Treatment for: Bacterial Infection
  Generic for: Firvanq
• Gadobutrol Intravenous Solution 1.20944 gm/2mL, 4.5354 gm/7.5mL, 6.0472 gm/10mL and 9.0708 gm/15mL
  Approved: November 17, 2022 - Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Treatment for: Contrast Agent for Magnetic Resonance Imaging (MRI)
  Generic for: Gadavist

September

• Riociguat Tablets 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg
  Approved: September 1, 2022 - MSN Laboratories Private Ltd.
  Treatment for: Pulmonary Hypertension
  Generic for: Adempas
• Cariprazine Hydrochloride Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base)
  Approved: September 9, 2022 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Schizophrenia
  Generic for: Vraylar
• Tazarotene Topical Gel 0.05%
  Approved: September 13, 2022 - Cosette Pharmaceuticals, Inc.
  Treatment for: Plaque Psoriasis
  Generic for: Tazorac Gel 0.05%
  
• Tazarotene Topical Gel 0.1%
  Approved: September 13, 2022 - Cosette Pharmaceuticals, Inc.
  Treatment for: Plaque Psoriasis; Acne Vulgaris
  Generic for: Tazorac Gel 0.1%
• Nebivolol Hydrochloride and Valsartan Tablets (Vyduo) 5 mg / 80 mg
  Approved: September 19, 2022 - Prinston Pharmaceutical Inc.
  Treatment for: Hypertension
  Generic for: Byvalson
• Gefitinib Tablets 250 mg
  Approved: September 23, 2022 - Apotex Inc.
  Treatment for: Non-Small Cell Lung Cancer
  Generic for: Iressa

August

• Empagliflozin Tablets 10 mg and 25 mg
  Approved: August 3, 2022 - Zydus Pharmaceuticals USA Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Jardiance
• Estradiol Transdermal Gel 0.1%
  Approved: August 10, 2022 - Chemo Research, S.L.
  Treatment for: Menopausal Vasomotor Symptoms
  Generic for: Divigel
• Brexpiprazole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
  Approved: August 11, 2022 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Depression
  Generic for: Rexulti
• Cetrorelix Acetate Powder for Subcutaneous Injection 0.25mg base/vial
  Approved: August 12, 2022 - Akorn Operating Company LLC
  Treatment for: Ovulation Induction
  Generic for: Cetrotide

July

• Empagliflozin and Metformin Hydrochloride Tablets 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5mg/1000 mg
  Approved: July 7, 2022 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Synjardy
• Citric Acid, Magnesium Oxide and Sodium Picosulfate for Oral Solution 12gm/3.5gm/10mg per packet
  Approved: July 18, 2022 - Hetero Labs Limited
  Treatment for: Bowel Preparation
  Generic for: Prepopik
• Azilsartan Kamedoxomil Tablets 40 mg and 80 mg (azilsartan medoxomil equivalent)
  Approved: July 20, 2022 - Lupin Pharmaceuticals, Inc.
  Treatment for: Hypertension
  Generic for: Edarbi

June

• Brivaracetam Tablets 10 mg, 25 mg, 50 mg, 75 mg and 100 mg
  Approved: June 9, 2022 - Sunshine Lake Pharma Co., Ltd.
  Treatment for: Epilepsy
  Generic for: Briviact
• Cabazitaxel Intravenous Solution 60 mg/1.5 mL (40 mg/mL)
  Approved: June 23, 2022 - Breckenridge Pharmaceutical, Inc.
  Treatment for: Prostate Cancer
  Generic for: Jevtana
• Abiraterone Acetate Tablets 125 mg
  Approved: June 24, 2022 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Prostate Cancer
  Generic for: Yonsa

May

• Estradiol and Progesterone Capsules 1 mg / 100 mg
  Approved: May 16, 2022 - Amneal Pharmaceuticals LLC
  Treatment for: Vasomotor Symptoms Due to Menopause
  Generic for: Bijuva
• Iodixanol Injection 55% and 65.2%
  Approved: May 19, 2022 - Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Treatment for: Radiographic Procedures
  Generic for: Visipaque 270 and Visipaque 320
• Lacosamide Oral Solution 10 mg /mL
  Approved: May 19, 2022 - Alkem Laboratories Ltd.
  Treatment for: Seizures
  Generic for: Vimpat Oral Solution
• Pemetrexed Disodium Injection 100 mg (base)/vial and 500 mg (base)/vial
  Approved: May 25, 2022 - Accord Healthcare, Inc.; Apotex Corp.; Dr. Reddys Laboratories Inc.; Eugia Pharma Specialities Limited; Fresenius Kabi USA, LLC; Hospira, Inc.; Jiangsu Hansoh Pharmaceutical Group Co., Ltd.; Nang Kuang Pharmaceutical Co., Ltd.; Qilu Pharmaceutical Co., Ltd.; Waverley Pharma Inc.; Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Mesothelioma, Non-Small Cell Lung Cancer
  Generic for: Alimta

April

• Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2% / 0.5% (base)
  Approved: April 4, 2022 - Sandoz Inc.
  Treatment for: Glaucoma
  Generic for: Combigan
• Lacosamide Injection 200 mg/20 mL (10 mg/mL)
  Approved: April 7, 2022 - Indoco Remedies Limited
  Treatment for: Seizures
  Generic for: Vimpat Injection
• Cysteine Hydrochloride Injection 500 mg/10 mL (50 mg/mL)
  Approved: April 8, 2022 - Eton Pharmaceuticals, Inc.
  Treatment for: Total Parenteral Nutrition
  Generic for: Elcys
• Regadenoson Intravenous Solution 0.4 mg/5 mL (0.08 mg/mL)
  Approved: April 11, 2022 - Accord Healthcare, Inc.; Apotex Inc.; Hong Kong King-Friend Industrial Co. Ltd.; Dr. Reddy's Laboratories Ltd.
  Treatment for: Myocardial Perfusion Imaging
  Generic for: Lexiscan
• Bexarotene Topical Gel 1%
  Approved: April 27, 2022 - Amneal Pharmaceuticals LLC
  Treatment for: Cutaneous T-Cell Lymphoma
  Generic for: Targretin Gel

March

• Methylphenidate Extended Release Transdermal Film 10 mg, 15 mg, 20 mg and 30 mg
  Approved: March 14, 2022 - Mylan Pharmaceuticals Inc.
  Treatment for: ADHD
  Generic for: Daytrana
• Budesonide and Formoterol Fumarate Dihydrate Metered Inhalation Aerosol 0.08 mg/0.0045 mg per inhalation and 0.16 mg/0.0045 mg per inhalation
  Approved: March 15, 2022 - Mylan Pharmaceuticals Inc.
  Treatment for: Asthma; COPD
  Generic for: Symbicort
• Lacosamide Tablets 50 mg, 100 mg, 150 mg and 200 mg
  Approved: March 17, 2022 - Alembic Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Glenmark Pharmaceuticals Inc.; Hetero Labs Limited; Indoco Remedies Limited; MSN Laboratories Private Limited; ScieGen Pharmaceuticals Inc., Sun Pharmaceutical Industries, Inc.
  Treatment for: Seizures
  Generic for: Vimpat
• Ioflupane I-123 Injection for Intravenous Use 185 MBq (5 mCi) in 2.5 mL
  Approved: March 30, 2022 - Curium US LLC
  Treatment for: Computed Tomography
  Generic for: DaTscan

February

• Cyclosporine Ophthalmic Emulsion 0.05%
  Approved: February 2, 2022 - Mylan Pharmaceuticals, Inc.
  Treatment for: Dry Eye Disease
  Generic for: Restasis
• Maraviroc Tablets 150 mg and 300 mg
  Approved: February 7, 2022 - Hetero Labs Limited
  Treatment for: HIV Infection
  Generic for: Selzentry
• Nalmefene Hydrochloride Injection 2 mg base /2 mL
  Approved: February 8, 2022 - Purdue Pharma LP
  Treatment for: Opioid Overdose
  Generic for: Revex
• Dapagliflozin Tablets 5 mg and 10 mg
  Approved: February 22, 2022 - Zydus Pharmaceuticals USA, Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Farxiga
• Apomorphine Hydrochloride Injection 30 mg /3 mL (10 mg /mL)
  Approved: February 23, 2022 - Sage Chemicals, Inc.
  Treatment for: Parkinson's Disease
  Generic for: Apokyn

January

• Pirfenidone Capsules 267 mg
  Approved: January 3, 2022 - Amneal Pharmaceuticals LLC
  Treatment for: Idiopathic Pulmonary Fibrosis
  Generic for: Esbriet
• Sofosbuvir Tablets 400 mg
  Approved: January 27, 2022 - Teva Pharmaceuticals USA, Inc.
  Treatment for: Hepatitis C
  Generic for: Sovaldi
• Brimonidine Tartrate Ophthalmic Solution 0.15%
  Approved: January 31, 2022 - Apotex Inc.
  Treatment for: Glaucoma
  Generic for: Alphagan P

December

• Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL
  Approved: December 2, 2021 - Par Pharmaceutical Inc.
  Treatment for: Urea Cycle Disorders
  Generic for: Ravicti (discontinued)
• Ivabradine Hydrochloride Tablets 5 mg (base) and 7.5 mg (base)
  Approved: December 30, 2021 - Centaur Pharmaceuticals Private Limited
  Treatment for: Heart Failure
  Generic for: Corlanor

November

• Valsartan Oral Solution 20 mg/5 mL
  Approved: November 2, 2021 - Novitium Pharma LLC
  Treatment for: Hypertension; Heart Failure
  Generic for: Prexxartan
• Nelarabine Injection 250 mg/50 mL (5 mg/mL)
  Approved: November 17, 2021 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
  Generic for: Arranon
• Dasatinib Tablets 80 mg and 140 mg
  Approved: November 23, 2021 - Apotex Corp.
  Treatment for: Ph+ Chronic Myeloid Leukemia; Ph+ Acute Lymphoblastic Leukemia
  Generic for: Sprycel
• Betaine for Oral Solution 1gm/scoopful
  Approved: November 23, 2021 - Novitium Pharma LLC
  Treatment for: Homocystinuria
  Generic for: Cystadane
• Lubiprostone Capsules 8 mcg and 24 mcg
  Approved: November 30, 2021 - Amneal Pharmaceuticals LLC
  Treatment for: Chronic Idiopathic Constipation; Opioid-Induced Constipation; Irritable Bowel Syndrome with Constipation
  Generic for: Amitiza

 

 

 

October

• Oxymetazoline Hydrochloride Topical Cream 1%
  Approved: October 4, 2021 - Taro Pharmaceuticals U.S.A., Inc.
  Treatment for: Rosacea
  Generic for: Rhofade (discontinued)
• Carglumic Acid Tablets for Oral Suspension 200 mg
  Approved: October 13, 2021 - Novitium Pharma LLC
  Treatment for: Hyperammonemia
  Generic for: Carbaglu

September

• Paroxetine Hydrochloride Oral Suspension 10mg (base) / 5 mL
  Approved: September 3, 2021 - Novitium Pharma LLC
  Treatment for: Depression
  Generic for: Paxil Oral Suspension
• Eliglustat Tartrate Capsules 84 mg (base)
  Approved: September 8, 2021 - Aizant Drug Research Solutions Pvt Ltd.
  Treatment for: Type 1 Gaucher Disease
  Generic for: Cerdelga
• Vortioxetine Hydrobromide Tablets 5 mg (base), 10 mg (base) and 20 mg (base)
  Approved: September 17, 2021 - Zydus Pharmaceuticals USA Inc.
  Treatment for: Depression
  Generic for: Trintellix
• Ceftaroline Fosamil for Injection 400  mg /vial and 600mg /vial
  Approved: September 21, 2021 - Apotex Inc.
  Treatment for: Pneumonia, Skin and Structure Infection
  Generic for: Teflaro
• Brimonidine Tartrate Topical Gel 0.33% (base)
  Approved: September 23, 2021 - Padagis Israel Pharmaceuticals Ltd.
  Treatment for: Rosacea
  Generic for: Mirvaso
• Zolmitriptan Nasal Spray 2.5 mg/spray and 5 mg/spray
  Approved: September 30, 2021 - Padagis Israel Pharmaceuticals Ltd.
  Treatment for: Migraine
  Generic for: Zomig

 

August

• Ibuprofen and Famotidine Tablets 800 mg / 26.6 mg
  Approved: August 3, 2021 - Alkem Laboratories Ltd.
  Generic for: Duexis
• Difluprednate Ophthalmic Emulsion 0.05%
  Approved: August 9, 2021 - Cipla Ltd.
  Generic for: Durezol
• Glycopyrrolate Oral Solution 1 mg / 5mL
  Approved: August 9, 2021 - Par Pharmaceutical Inc.
  Generic for: Cuvposa
• Enalapril Maleate Oral Solution 1 mg / mL
  Approved: August 10, 2021 - Bionpharma Inc.
  Generic for: Epaned
• Varenicline Tablets 0.5 mg (base) and 1 mg (base)
  Approved: August 11, 2021 - Par Pharmaceutical Inc.
  Generic for: Chantix
• Sunitinib Malate Capsules 12.5 mg (base), 25 mg (base), 37.5 mg (base), 50 mg (base) 
  Approved: August 16, 2021 - Sun Pharmaceutical Industries, Inc.
  Generic for: Sutent
• Tofacitinib Citrate Extended Release Tablets 11 mg (base) and 22 mg (base)
  Approved: August 19, 2021 - Zydus Pharmaceuticals USA Inc.
  Generic for: Xeljanz XR
• Linagliptin and Metformin Hydrochloride Tablets 2.5mg / 500mg, 2.5mg / 850mg and 2.5mg / 1000 mg
  Approved: August 30, 2021 - Sunshine Lake Pharma Co., Ltd.
  Generic for: Jentadueto
• Linagliptin Tablets 5 mg
  Approved: August 31, 2021 - Sunshine Lake Pharma Co., Ltd.
  Generic for: Tradjenta

 

July

• Paliperidone Palmitate Extended Release Intramuscular Suspension 39 mg / 0.25 mL, 78 mg / 0.5 mL, 117 mg / 0.75 mL, 156 mg / mL, 234 mg / 1.5 mL
  Approved: July 6, 2021 - Teva Pharmaceuticals USA, Inc.
  Generic for: Invega Sustenna

 

 

June

• Tofacitinib Citrate Tablets 10 mg (base)
  Approved: June 1, 2021 - Ajanta Pharma Limited
  Generic for: Xeljanz
• Lopinavir and Ritonavir Tablets 100 mg / 25 mg and 200 mg / 50 mg
  Approved: June 4, 2021 - Hetero Labs Limited
  Generic. for: Kaletra Tablets
• Etravirine Tablets 25 mg, 100 mg and 200 mg
  Approved: June 14, 2021 - Amneal Pharmaceuticals LLC
  Generic for: Intelence
• Formoterol Fumarate Inhalation Solution 0.02 mg / 2 mL
  Approved: June 22, 2021 - Teva Pharmaceuticals USA, Inc.
  Generic for: Perforomist
• Arformoterol Tartrate Inhalation Solution 0.015mg (base) / 2 mL
  Approved: June 22, 2021 - Axar Pharmaceuticals, Inc.; Cipla USA Inc.; Glenmark Pharmaceuticals Inc., USA
  Generic for: Brovana
• Eslicarbazepine Acetate Tablets 200 mg, 400 mg, 600 mg and 800 mg
  Approved: June 29, 2021 - Dr. Reddys Laboratories Inc.
  Generic for: Aptiom

May

• Enzalutamide Capsules 40 mg
  Approved: May 14, 2021 - Actavis Pharma, Inc.
  Generic for: Xtandi
• Lenalidomide Capsules 5 mg, 10 mg, 15 mg and 25 mg
  Approved: May 21, 2021 - Natco Pharma Ltd.
  Generic for: Revlimid

April

• Deoxycholic Acid Subcutaneous Solution 20 mg / 2mL
  Approved: April 2, 2021 - Slayback Pharma LLC
  Generic for: Kybella
• Macitentan Tablets 10 mg
  Approved: April 6, 2021 - Zydus Pharmaceuticals (USA) Inc.
  Generic for: Opsumit
• Tiopronin Tablets 100 mg
  Approved: April 26, 2021 - Teva Pharmaceuticals USA, Inc.
  Generic for: Thiola

March

• Hydrocodone Bitartrate Extended Release Tablets 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120mg
  Approved: March 1, 2021 - Alvogen, Inc.
  Generic for: Hysingla ER
• Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg
  Approved: March 31, 2021 - Actavis Pharma, Inc.
  Generic for: Absorica

February

• Linaclotide Capsules 145 mcg and 290 mcg
  Approved: February 9, 2021 - Mylan Pharmaceuticals Inc.
  Generic for: Linzess
• Loteprednol Etabonate Ophthalmic Gel 0.5%
  Approved: February 10, 2021 - Akorn Operating Company LLC
  Generic for: Lotemax Gel
• Apremilast Tablets 10 mg, 20 mg and 30 mg
  Approved: February 17, 2021 - Unichem Laboratories Ltd.
  Generic for: Otezla
• Droxidopa Capsules 100 mg, 200 mg and 300 mg
  Approved: February 18, 2021 - Ajanta Pharma Limited; Alkem Laboratories Limited; Annora Pharma Private Limited; Aurobindo Pharma Limited; Hikma Pharmaceuticals USA Inc.; Lundbeck Pharmaceuticals LLC; Lupin Pharmaceuticals, Inc.; MSN Laboratories Private Limited; ScieGen Pharmaceuticals, Inc.; Sun Pharmaceutical Industries, Inc.; Tasman Pharma Inc.; Teva Pharmaceuticals USA, Inc.; Zydus Pharmaceuticals (USA) Inc.
  Generic for: Northera

January

• Ferumoxytol Intravenous Solution  eq 510mg Iron/17mL
  Approved: January 15, 2021 - Sandoz Inc.
  Generic for: Feraheme
• Imiquimod Topical Cream 3.75%
  Approved: January 26, 2021 - Taro Pharmaceutical Industries Ltd.
  Generic for: Zyclara

December

• Efinaconazole Topical Solution 10%
  Approved: December 16, 2020 - Perrigo Pharma International DAC; Teva Pharmaceuticals USA, Inc.
  Generic for: Jublia

November

• Gemmily (ethinyl estradiol and norethindrone acetate) Capsules 0.02 mg / 1 mg
  Approved: November 9, 2020 - Chemo Research SL
  Generic for: Taytulla
• Brinzolamide Ophthalmic Suspension 1%
  Approved: November 27, 2020 - Watson Laboratories Inc.
  Generic for: Azopt
• Nitazoxanide Tablets 500 mg
  Approved: November 27, 2020 - Rising Pharma Holdings Inc.
  Generic for: Alinia

October

• Fosfomycin Tromethamine Granules for Oral Solution 3 grams (base)/single-dose sachet
  Approved: October 6, 2020 - Xiromed Pharma España, S.L
  Generic for: Monurol
• Azelaic Acid Topical Foam 15%
  Approved: October 7, 2020 - Teva Pharmaceuticals USA, Inc.
  Generic for: Finacea
• Tavaborole Topical Solution 5%
  Approved: October 13, 2020 - Perrigo Pharma International DAC; Encube Ethicals Private Limited
  Generic for: Kerydin
• Pomalidomide Capsules 1 mg, 2 mg, 3 mg and 4 mg
  Approved: October 30, 2020 - Breckenridge Pharmaceutical, Inc.; Eugia Pharma Specialities Ltd.
  Generic for: Pomalyst
• Levothyroxine Sodium Capsules 0.075 mg and 0.15 mg
  Approved: October 28, 2020 - Teva Pharmaceuticals USA, Inc.
  Generic for: Tirosint

September

• Lapatinib Ditosylate Tablets 250 mg (base)
  Approved: September 29, 2020 - Natco Pharma Limited
  Generic for: Tykerb

August

• Ciprofloxacin and Dexamethasone Otic Suspension/Drops 0.3% / 0.1%
  Approved: August 10, 2020 - Dr. Reddy's Laboratories Ltd.
  Generic for: Ciprodex
• Dimethyl Fumarate Delayed Release Capsules 120 mg and 240 mg
  Approved: August 17, 2020 - Mylan Pharmaceuticals, Inc.
  Generic for: Tecfidera

July

• Deferasirox Oral Granules 90 mg, 180 mg and 360 mg
  Approved: July 14, 2020 - Alkem Laboratories Ltd.
  Generic for: Jadenu Sprinkle
• Metyrosine Capsules 250 mg
  Approved: July 24, 2020 - Amneal Pharmaceuticals LLC
  Generic for: Demser

June

 

• Methylphenidate Hydrochloride Extended-Release Orally Disintegrating Tablets 8.6 mg, 17.3 mg and 25.9 mg
  Approved: June 19, 2020 -  Actavis Elizabeth LLC
  Generic for: Cotempla XR-ODT
• Pantoprazole Sodium for Delayed-Release Oral Suspension 40 mg (base)
  Approved: June 30, 2020 - Sun Pharmaceutical Industries Ltd.
  Generic for: Protonix for Delayed-Release Oral Suspension

May

• Ivermectin Lotion 0.5%
  Approved: May 6, 2020 - Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Sklice
• Desonide Topical Gel 0.05%
  Approved: May 11, 2020 - Teresina Holdings LLC
  Generic for: Desonate Gel
• Calcipotriene and Betamethasone Dipropionate Topical Suspension 0.005% / 0.064%
  Approved: May 11, 2020 - Tolmar Pharmaceuticals Inc.
  Generic for: Taclonex Scalp
  
• Posaconazole Oral Suspension 40mg/ mL
  Approved: May 15, 2020 - Hikma Pharmaceuticals USA Inc.
  Generic for: Noxafil Oral Suspension
• Icosapent Ethyl Capsules 1 gm
  Approved: May 21, 2020 - Hikma Pharmaceuticals USA Inc.
  Generic for: Vascepa

April

• Albuterol Sulfate Metered Inhalation Aerosol 0.09mg base/inhalation
  Approved: April 8, 2020 - Cipla USA Inc.
  Generic for: Proventil HFA
• Clocortolone Pivalate Cream 0.1%
  Approved: April 22, 2020 - Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Cloderm

March

• Metformin Hydrochloride Oral Solution 500mg/ 5mL
  Approved: March 3, 2020 - Saptalis Pharmaceuticals, LLC
  Generic for: Riomet
• Dabigatran Etexilate Mesylate Capsules 75 mg (base) and 150 mg (base)
  Approved: March 11, 2020 - Alkem Laboratories Ltd.
  Generic for: Pradaxa
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 10 mg base/packet, 20mg base/packet and 40mg base/packet
  Approved: March 23, 2020 - Cipla USA Inc.
  Generic for: Nexium Granules for Oral Suspension

February

• Sodium Iodide I 131 Solution USP and Sodium Iodide I 131 Capsules USP ,1000 mCi/mL
  Approved: February 5, 2020 - International Isotopes, Inc.
  Generic for: Hicon (Sodium Iodide I 131) Solution and Capsules, 1000 mCi/mL,
• Naproxen and Esomeprazole Magnesium Delayed-Release Tablets 375/20 mg and 500/20 mg
  Approved: February 18, 2020 - Dr. Reddy's Laboratories
  Generic for: Vimovo
• Olopatadine Hydrochloride Ophthalmic Solution 0.7% (base)
  Approved: February 19, 2020 - Watson Laboratories, Inc.
  Generic for: Pazeo
• Albuterol Sulfate Inhalation Aerosol 90 mcg/actuation
  Approved: February 24, 2020 - Perrigo Pharmaceuticals Company
  Generic for: ProAir HFA
• Pyrimethamine Tablets 25 mg
  Approved: February 26, 2020 - Cerovene, Inc.
  Generic for: Daraprim
• Dihydroergotamine (nasal) 4 mg/mL
  Approved: February 28, 2020 - Cerovene, Inc.
  Generic for: Migranal

January

• Hydrocodone Bitartrate Extended Release Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg
  Approved: January 21, 2020 - Alvogen Inc.
  Generic for: Zohydro ER

December

• Sucralfate Oral Suspension 1 gm/10mL
  Approved: December 2, 2019 - Amneal Pharmaceuticals LLC
  Generic for: Carafate Oral Suspension
• Fingolimod Hydrochloride Capsules 0.5 mg (base)
  Approved: December 4, 2019 - Biocon Pharma Inc.; HEC Pharm USA Inc.; Sun Pharmaceutical Industries, Inc.
  Generic for: Gilenya
• Everolimus Tablets 2.5 mg, 5 mg, 7.5 mg, and 10 mg
  Approved: December 9, 2019 - Teva Pharmaceuticals USA, Inc.; Par Pharmaceutical Inc. (excl. 10 mg)
  Generic for: Afinitor
• Sodium Tetradecyl Sulfate Injection 60 mg/2mL
  Approved: December 9, 2019 - Custopharm, Inc.
  Generic for: Sotradecol
• Etonogestrel and Ethinyl Estradiol Vaginal Ring (EluRyng) 0.120 mg/0.015 mg per day
  Approved: December 11, 2019 - Amneal Pharmaceuticals LLC
  Generic for: NuvaRing
• Alvimopan Capsules 12 mg
  Approved: December 19, 2019 - Watson Laboratories Inc.
  Generic for: Entereg
• Diazoxide Oral Suspension 50 mg/mL
  Approved: December 20, 2019 - E5 Pharma Inc.
  Generic for: Proglycem Oral Suspension
• Apixaban Tablets 2.5 mg and 5 mg
  Approved: December 23, 2019 - Mylan Pharmaceuticals Inc.; Micro Labs Limited
  Generic for: Eliquis
• Ziprasidone Mesylate Injection 20 mg (base) /mL
  Approved: December 26, 2019 - Gland Pharma Limited
  Generic for: Geodon Injection
• Mirabegron Extended Release Tablets 25 mg
  Approved: December 27, 2019 - Sawai USA Inc.
  Generic for: Myrbetriq

 

November

• Gadoterate Meglumine Injection (Clariscan) 5 mmol /10 mL, 7.5 mmol/15 mL and 10 mmol/20 mL Single-Dose Vials
  Approved: November 1, 2019 - GE Healthcare Inc.
  Generic for: Dotarem
• Mesalamine Extended-Release Capsules, USP 0.375 g
  Approved: November 1, 2019 - Mylan Pharmaceuticals Inc.
  Generic for: Apriso
• Deferasirox Tablets 90 mg, 180 mg and 360 mg
  Approved: November 20, 2019 - Alembic Pharmaceuticals Limited; MSN Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Zydus Pharmaceuticals (USA), Inc.
  Generic for: Jadenu

October

• Digoxin Oral Elixir 0.05mg/mL
  Approved: October 4, 2019 - Novitium Pharma LLC

September

• Carfilzomib for Injection 60mg/vial
  Approved: September 9, 2019 - Dr. Reddy's Laboratories, Inc.
  Generic for: Kyprolis 60mg/vial
• Ivermectin Topical Cream 1%
  Approved: September 13, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Soolantra
• Vilazodone Hydrochloride Tablets 10 mg, 20 mg, and 40 mg
  Approved: September 30, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Viibryd

August

• Halcinonide Topical Cream 0.1%
  Approved: August 12, 2019 - Mylan Pharmaceuticals Inc.
  Generic for: Halog Cream
• Levocarnitine SF Oral Solution 1 gram/10mL
  Approved: August 14, 2019 - Novitium Pharma LLC
  Generic for: Carnitor SF
• Tafluprost Ophthalmic Solution/Drops 0.0015%
  Approved: August 19, 2019 - Micro Labs Limited
  Generic for: Zioptan
• Sapropterin Dihydrochloride Oral Powder 100mg/packet and 500mg/packet
  Approved: August 20, 2019 - Par Pharmaceutical, Inc.
  Generic for: Kuvan Powder for Oral Solution
• Posaconazole Delayed Release Tablets 100 mg
  Approved: August 21, 2019 - Sinotherapeutics Inc.
  Generic for: Noxafil Tablets
• Nitisinone Capsules 2 mg, 5 mg and 10 mg
  Approved: August 26, 2019 - Novitium Pharma LLC
  Generic for: Orfadin Capsules

July

• Febuxostat Tablets 40 mg and 80 mg
  Approved: July 1, 2019 - Mylan Pharmaceuticals Inc.; Alembic Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
  Generic for: Uloric
• Ketorolac Tromethamine and Phenylephrine Hydrochloride Irrigation Solution 0.3% (base)/1% (base)
  Approved: July 1, 2019 - Lupin Pharmaceuticals, Inc.
  Generic for: Omidria
• Carboprost Tromethamine Injection 0.25mg (base)/mL
  Approved: July 2, 2019 - Dr. Reddy's Laboratories Limited
  Generic for: Hemabate
  
• Icatibant Acetate Injection 30mg base/3mL
  Approved: July 15, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Firazyr
• Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
  Approved: July 19, 2019 - Alembic Pharmaceuticals Inc.; Alkem Laboratories Ltd.; Amneal Pharmaceuticals LLC; Dr. Reddy's Laboratories Limited; InvaGen Pharmaceuticals, Inc.; MSN Laboratories Private Ltd.; Rising Pharmaceuticals, Inc.; Sciegen Pharmaceuticals Inc.; Teva Pharmaceuticals USA, Inc.
  Generic for: Lyrica Capsules
• Pregabalin Oral Solution 20 mg/mL
  Approved: July 19, 2019 - Alkem Laboratories Ltd.
  Generic for: Lyrica Oral Solution

June

• Diclofenac Sodium Injection 37.5 mg/mL Single-Dose Vials
  Approved: June 18, 2019 - Mylan Laboratories Limited
  Generic for: Dyloject
• Tobramycin Inhalation Solution 300 mg/4 mL (discontinued)
  Approved: June 26, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Bethkis

May

• Penicillamine Capsules USP, 250 mg
  Approved: May 7, 2019 - Amerigen Pharmaceuticals, Ltd.
  Generic for: Cuprimine
• Mesalamine Delayed-Release Capsules 400 mg
  Approved: May 9, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Delzicol
• Sapropterin Dihydrochloride Tablets 100 mg
  Approved: May 10, 2019 - Par Pharmaceutical, Inc.
  Generic for: Kuvan
• Micafungin Sodium Injection 50 mg (base)/vial and 100 mg (base)/vial
  Approved: May 17, 2019 - Fresenius Kabi USA, LLC
  Generic for: Mycamine
• Sildenafil Citrate for Oral Suspension 10mg (base)/mL
  Approved: May 31, 2019 - Novitium Pharma LLC
  Generic for: Revatio for Oral Suspension

April

• Naftifine Hydrochloride Topical Gel 2%
  Approved: April 10, 2019 - Taro Pharmaceuticals Inc.
  Generic for: Naftin Gel 2%
• Mifepristone Tablets 200 mg
  Approved: April 11, 2019 - GenBioPro Inc.
  Generic for: Mifeprex
• Loteprednol Etabonate Ophthalmic Suspension 0.5%
  Approved: April 17, 2019 - Hi-Tech Pharmacal Co., Inc.
  Generic for: Lotemax Ophthalmic Suspension 0.5%
• Valrubicin Intravesical Solution 40mg/mL
  Approved: April 19, 2019 - Custopharm, Inc.
  Generic for: Valstar
• Naloxone Hydrochloride Nasal Spray 4mg/spray
  Approved: April 19, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Narcan Nasal Spray
• Everolimus Tablets for Oral Suspension 2 mg, 3 mg, and 5 mg
  Approved: April 19, 2019 - Mylan Pharmaceuticals, Inc.
  Generic for: Afinitor Disperz
• Rufinamide Oral Suspension 40mg/mL
  Approved: April 23, 2019 - Bionpharma, Inc.; Hikma Pharmaceuticals USA Inc.
  Generic for: Banzel Oral Suspension
• Pentamidine Isethionate for Inhalation Solution 300mg/vial
  Approved: April 24, 2019 - Seton Pharmaceuticals
  Generic for: Nebupent
• Bosentan Tablets 62.5 mg and 125 mg
  Approved: April 26, 2019 - Alvogen Inc.; Amneal Pharmaceuticals LLC; Natco Pharma Ltd.; Par Pharmaceutical, Inc.; Sun Pharmaceutical Industries, Inc.; Watson Labs Inc.; West-Ward Pharmaceuticals Corp.; Zydus Pharmaceuticals (USA) Inc.
  Generic for: Tracleer

March

• Fulvestrant Injection 50mg/mL
  Approved: March 4, 2019 - Amneal Pharmaceuticals LLC
  Generic for: Faslodex
• Bepotastine Besilate Ophthalmic Drops 1.5 %
  Approved: March 5, 2019 - Apotex Corporation
  Generic for: Bepreve
• Pyridostigmine Bromide Syrup 60 mg/5 mL
  Approved: March 8, 2019 - Novitium Pharma LLC
  Generic for: Mestinon Syrup
• Naftifine Hydrochloride Topical Gel 1%
  Approved: March 20, 2019 - Tolmar Inc.
  Generic for: Naftin Gel 1%
• Aliskiren Hemifumarate Tablets 150 mg (base) and 300 mg (base)
  Approved: March 22, 2019 - Anchen Pharmaceuticals, Inc.
  Generic for: Tekturna
• Ambrisentan Tablets 5 mg and 10 mg
  Approved: March 28, 2019 - Watson Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Zydus Pharmaceuticals (USA) Inc.; Sun Pharmaceutical Industries, Inc.
  Generic for: Letairis

February

• Acyclovir Cream 5%
  Approved: February 4, 2019 - Perrigo UK Finco Limited Partnership
  Generic for: Zovirax Cream
• Levomilnacipran Hydrochloride Extended Release Capsules 20 mg (base), 40 mg (base), 80 mg (base) and 120 mg (base)
  Approved: February 4, 2019 - Amneal Pharmaceuticals LLC
  Generic for: Fetzima
• Sevelamer Hydrochloride Tablets 400 mg and 800 mg
  Approved: February 8, 2019 - Glenmark Pharmaceuticals Inc., USA
  Generic for: Renagel
• Deferiprone Tablets 500 mg
  Approved: February 8, 2019 - Taro Pharmaceuticals Industries Limited
  Generic for: Ferriprox Tablets
• Levofloxacin Ophthalmic Solution 1.5%
  Approved: February 27, 2019 - Micro Labs Limited
  Generic for: Iquix

January

• Lurasidone Hydrochloride Tablets 20 mg, 40 mg, 60 mg, 80 mg and 120 mg
  Approved: January 3, 2019 - Amneal Pharmaceuticals LLC; InvaGen Pharmaceuticals Inc.; Lupin Pharmaceuticals, Inc.; Accord Healthcare Inc.; Torrent Pharmaceuticals Limited
  Generic for: Latuda
• Ingenol Mebutate Topical Gel 0.015%
  Approved: January 7, 2019 - Perrigo
  Generic for: Picato Gel 0.015%
• Ingenol Mebutate Topical Gel 0.05%
  Approved: January 9, 2019 - Perrigo
  Generic for: Picato Gel 0.05%
• Vigabatrin Tablets 500 mg
  Approved: January 14, 2019 - Teva Pharmaceuticals USA, Inc.
  Generic for: Sabril
• Sirolimus Oral Solution 1 mg/mL
  Approved: January 28, 2019 - Novitium Pharma LLC
  Generic for: Rapamune Oral Solution
• Wixela Inhub (fluticasone propionate and salmeterol inhalation powder) 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg
  Approved: January 30, 2019 - Mylan N.V.
  Generic for: Advair Diskus

December

• Toremifene Citrate Tablets 60 mg (base)
  Approved: December 4, 2018 - Eirgen Pharma Ltd.
  Generic for: Fareston
• Pimecrolimus Topical Cream 1%
  Approved: December 27, 2018 - Actavis Laboratories UT, Inc.
  Generic for: Elidel

November

• Vardenafil Hydrochloride Orally Disintegrating Tablets 10 mg
  Approved: November 16, 2018 - Alembic Pharmaceuticals Ltd.
  Generic for: Staxyn
• Azelaic Acid Topical Gel 15%
  Approved: November 19, 2018 - Actavis Laboratories UT Inc.; Glenmark Pharmaceuticals; Tolmar Inc.
  Generic for: Finacea Gel
• Docosanol Cream 10%
  Approved: November 19, 2018 - Actavis Laboratories UT, Inc.
  Generic for: Abreva
• Buprenorphine Transdermal System 5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour
  Approved: November 20, 2018 - Watson Laboratories, Inc.
  Generic for: Butrans
• Colchicine Capsules 0.6 mg
  Approved: November 29, 2018 - Par Pharmaceutical Inc.
  Generic for: Mitigare
• Bismuth Subsalicylate, Metronidazole and Tetracycline Hydrochloride Chewable Tablets 262.4 mg / Tablets 250 mg / Capsules 500 mg
  Approved: November 30, 2018 - Ailex Pharmaceuticals LLC
  Generic for: Helidac

October

• Cefixime Capsules 400 mg
  Approved: October 9, 2018 - Alkem Laboratories Limited
  Generic for: Suprax Capsules
• Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%
  Approved: October 17, 2018 - Taro Pharmaceuticals USA, Inc.
  Generic for: Epiduo Forte
• Clobazam Tablets 10 mg and 20 mg
  Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Breckenridge Pharmaceutical, Inc.; Camber Pharmaceuticals, Inc.; Sandoz Inc.; Taro Pharmaceuticals U.S.A., Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.; Zydus Pharmaceuticals (USA) Inc.
  Generic for: Onfi Tablets
• Clobazam Oral Suspension 2.5 mg/mL
  Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Mylan Pharmaceuticals Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.
  Generic for: Onfi Oral Suspension
• Naproxen Sodium and Diphenhydramine Hydrochloride Tablets 220mg/25mg
  Approved: October 23, 2018 - Amneal Pharmaceuticals LLC
  Generic for: Aleve PM
• Abiraterone Acetate Tablets 250 mg
  Approved: October 31, 2018 - Apotex, Inc.; Hikma Pharmaceuticals LLC; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.
  Generic for: Zytiga 250 mg

September

• Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600 mg/200 mg/300 mg
  Approved: September 4, 2018 - Aurobindo Pharma Limited
  Generic for: Atripla
• Ticagrelor Tablets 60mg and 90mg
  Approved: September 4, 2018 - Watson Laboratories, Inc.
  Generic for: Brilinta
• Carmustine for Injection USP, 100 mg/vial
  Approved - September 11, 2018 - Navinta LLC
  Generic for: BiCNU
• Albendazole Tablets 200 mg
  Approved: September 21, 2018 - Cipla Ltd.
  Generic for: Albenza

August

• Tadalafil Tablets 20mg
  Approved: August 3, 2018 - Mylan Pharmaceuticals Inc.
  Generic for: Adcirca
• Epinephrine (Autoinjector) Injection 0.15 mg/delivery and 0.3 mg/delivery
  Approved: August 16, 2018 - Teva Pharmaceuticals USA, Inc.
  Generic for: EpiPen Jr. and EpiPen
• Arsenic Trioxide Injection 10 mg/10 mL Single-dose Vial
  Approved: August 31, 2018 - Fresenius Kabi USA, LLC
  Generic for: Trisenox

July

• Emtricitabine Capsules 200 mg
  Approved: July 2, 2018 - Cipla USA Inc.
  Generic for: Emtriva
• Budesonide Extended-Release Tablets 9 mg
  Approved: July 3, 2018 - Actavis Laboratories FL, Inc.
  Generic for: Uceris Extended-Release Tablets
• Roflumilast Tablets 500 mcg
  Approved: July 13, 2018 - Mylan Pharmaceuticals Inc.
  Generic for: Daliresp
• Colesevelam Hydrochloride for Oral Suspension 1.875 grams/packet and 3.75 grams/packet
  Approved: July 16, 2018 - Glenmark Pharmaceuticals Inc.
  Generic for: Welchol for Oral Suspension
• Asenapine Maleate Sublingual Tablets 5 mg (base) and 10 mg (base)
  Approved: July 17, 2018 - Sigmapharm Laboratories LLC
  Generic for: Saphris
• Teriflunomide Tablets 7 mg and 14 mg
  Approved: July 27, 2018 - Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
  Generic for: Aubagio
• Temsirolimus Intravenous Solution 25 mg/mL
  Approved: July 30, 2018 - Accord Healthcare Inc.
  Generic for: Torisel

June

• Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/ 3.75%
  Approved: June 5, 2018 - Taro Pharmaceuticals Inc.
  Generic for: Onexton
• Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg, 8 mg/2 mg, 4 mg/1 mg and 12 mg/3 mg
  Approved: June 14, 2018 - Dr. Reddy's Laboratories SA; Mylan Technologies Inc. (8 mg/2 mg and 12 mg/3 mg only)
  Generic for: Suboxone Sublingual Film

May

• Phytonadione Tablets 5 mg
  Approved: May 11, 2018 - Amneal Pharmaceuticals LLC
  Generic for: Mephyton
• Colesevelam Hydrochloride Tablets 625mg
  Approved: May 16, 2018 - Impax Laboratories, Inc.
  Generic for: Welchol
• Methylphenidate Hydrochloride for Extended Release Oral Suspension 5 mg/mL
  Approved: May 17, 2018 - Actavis Pharma, Inc.
  Generic for: Quillivant XR
• Tadalafil Tablets 2.5mg, 5mg, 10mg and 20mg
  Approved: May 22, 2018 - Teva Pharmaceuticals USA, Inc.
  Generic for: Cialis
• Oxybutynin Chloride Transdermal Gel 10% (100mg/packet)
  Approved: May 31, 2018 - Par Pharmaceutical, Inc.
  Generic for: Gelnique

April

• Everolimus Tablets 0.25 mg, 0.5 mg and 0.75 mg
  Approved: April 12, 2018 - West-Ward Pharmaceuticals Corp.
  Generic for: Zortress
• Ertapenem Sodium for Injection 1 gram (base)/vial
  Approved: April 16, 2018 - ACS Dobfar S.p.A.
  Generic for: Invanz
• Miglustat Capsules 100 mg
  Approved: April 17, 2018 - Amerigen Pharmaceuticals, Inc.
  Generic for: Zavesca
• Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL and 100 mg/10 mL
  Approved: April 27, 2018 - Cipla USA Inc.
  Generic for: Vazculep

March

• Cinacalcet Hydrochloride Tablets 30 mg (base), 60 mg (base), and 90 mg (base)
  Approved: March 8, 2018 - Cipla Ltd.; Aurobindo Pharma Limited
  Generic for: Sensipar

February

• Trientine Hydrochloride Capsules 250mg
  Approved: February 7, 2018 - Actavis Pharma, Inc.
  Generic for: Syprine
• Sumatriptan Succinate and Naproxen Sodium Tablets 85mg (base)/ 500mg (base)
  Approved: February 15, 2018 - Aurobindo Pharma Limited
  Generic for: Treximet

January

• Potassium Chloride Extended-Release Tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg)
  Approved: January 12, 2018 - Paddock Laboratories, LLC
  Generic for: K-Tab
• Remifentanil Hydrochloride Injection 1 mg base/vial, 2 mg base/vial and 5mg base/vial
  Approved: January 16, 2018 - Fresenius Kabi USA, LLC
  Generic for: Ultiva
• Levocetirizine Dihydrochloride Tablets USP, 5 mg
  Approved: January 19, 2018 - Dr. Reddy’s Laboratories Limited
  Generic for: Xyzal Allergy 24HR
• Tenofovir Disoproxil Fumarate Tablets 150 mg, 200 mg and 250 mg
  Approved: January 26, 2018 - Aurobindo Pharma Limited; Teva Pharmaceuticals USA, Inc.
  Generic for: Viread 150 mg, 200 mg and 250 mg

December

• Ibuprofen and Pseudoephedrine Hydrochloride Capsules 200 mg/ 30 mg (OTC)
  Approved: December 1, 2017 - Aurobindo Pharma Limited
  Generic for: Advil Cold and Sinus Liqu-Gels
• Triamcinolone Acetonide Injectable Suspension USP 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) multi-dose vials and 400 mg/10 mL (40 mg/mL) multi-dose vials
  Approved: December 13, 2017 - Amneal Pharmaceuticals Company
  Generic for: Kenalog-40 Injection
  
• Efavirenz Capsules 50mg, 100mg and 200mg
  Approved: December 15, 2017 - Aurobindo Pharma Limited
  Generic for: Sustiva Capsules
• Estradiol Vaginal Cream USP, 0.01%
  Approved: December 29, 2017 - Mylan Pharmaceuticals Inc.
  Generic for: Estrace Vaginal Cream

November

• Butenafine Hydrochloride Topical Cream 1% (OTC)
  Approved: November 16, 2017 - Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Lotrimin Ultra
• Darunavir Ethanolate Tablets 600 mg (base)
  Approved: November 21, 2017 - Teva Pharmaceuticals USA, Inc.
  Generic for: Prezista Tablets 600 mg
• Capreomycin Sulfate Injection 1 gram (base) /vial
  Approved: November 27, 2017 - Mylan Pharmaceuticals Inc.
  Generic for: Capastat Sulfate
• Praziquantel Tablets 600mg
  Approved: November 27, 2017 - Par Pharmaceutical, Inc.
  Generic for: Biltricide

October

• Glatiramer Acetate Injection 40 mg/mL
  Approved: October 3, 2017 - Mylan Pharmaceuticals Inc.
  Generic for: Copaxone 40 mg/mL
• Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules 20mg/10mg
  Approved: October 10, 2017 - Actavis Pharma, Inc.
  Generic for: Nuedexta
• Dapsone Gel 5%
  Approved: October 16, 2017 - Taro Pharmaceuticals USA
  Generic for: Aczone
• Carvedilol Phosphate Extended Release Capsules 10 mg, 20 mg, 40 mg and 80 mg
  Approved: October 25, 2017 - Sun Pharmaceutical Industries Limited
  Generic for: Coreg CR

September

• Oseltamivir Phosphate for Oral Suspension 6 mg (base)/mL
  Approved: September 14, 2017 - Nesher Pharmaceuticals (USA) LLC
  Generic for: Tamiflu for Oral Suspension

August

• Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL single-dose vials
  Approved: August 2, 2017 - Nexus Pharmaceuticals, Inc.
  Generic for: Isuprel Injection
• Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base) and 1 gram (base)
  Approved: August 11, 2017 - Natco Pharma Limited
  Generic for: Fosrenol Chewable Tablets
• Esomeprazole Magnesium Delayed-Release Capsules 20 mg (OTC)
  Approved: August 18, 2017 - Perrigo Pharmaceuticals Company
  Generic for: Nexium 24HR Capsules (OTC)
• Ephedrine Sulfate Injection USP, 50 mg/mL Single-Dose Vial
  Approved: August 23, 2017 - Sandoz Inc.
  Generic for: Akovaz
• Tacrolimus Injection 5mg (base)/mL
  Approved: August 25, 2017 - Hospira, Inc.
  Generic for: Prograf Injection

July

• Prasugrel Tablets 5 mg and 10 mg
  Approved: July 12, 2017 - Mylan Pharmaceuticals Inc.
  Generic for: Effient
• Sevelamer Carbonate Tablets 800mg
  Approved: July 17, 2017 - Aurobindo Pharma Limited
  Generic for: Renvela Tablets
• Mesalamine Delayed-Release Tablets USP, 800 mg
  Approved: July 21, 2017 - Zydus Pharmaceuticals (USA) Inc.
  Generic for: Asacol HD
• Minoxidil Topical Aerosol 5% (for Women)
  Approved: July 27, 2017 - Watson Laboratories, Inc.
  Generic for: Women's Rogaine

June

• Mesalamine Delayed-Release Tablets USP, 1.2 g
  Approved: June 5, 2017 - Zydus Pharmaceuticals (USA) Inc.
  Generic for: Lialda
• Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg
  Approved: June 8, 2017 - Teva Pharmaceuticals USA
  Generic for: Truvada
• Sevelamer Carbonate for Oral Suspension 800 mg/packet and 2.4 g/packet
  Approved: June 13, 2017 - Aurobindo Pharma Ltd.
  Generic for: Renvela for Oral Suspension
• Doxycycline Hyclate Tablets USP, 75 mg and 150 mg
  Approved: June 14, 2017 - Mayne Pharma, Inc.
  Generic for: Acticlate
• Eletriptan Hydrobromide Tablets 20 mg (base) and 40 mg (base)
  Approved: June 16, 2017 - Zydus Pharmaceuticals USA, Inc.
  Generic for: Relpax
• Paroxetine Mesylate Capsules 7.5 mg
  Approved: June 20, 2017 - Actavis Laboratories FL, Inc.
  Generic for: Brisdelle
• Phentermine Hydrochloride Orally Disintegrating Tablets 15 mg, 30 mg and 37.5 mg
  Approved: June 28, 2017 - Zydus Pharmaceuticals (USA) Inc.
  Generic for: Suprenza

May

• Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg
  Approved: May 9, 2017 - IntelliPharmaCeutics Corp.; Par Pharmaceutical Inc.; Pharmadax Inc.; Accord Healthcare Inc.
  Generic for: Seroquel XR
• Clofarabine Injection 20 mg/20 mL Single-Use Vial
  Approved: May 9, 2017 - Abon Pharmaceuticals, LLC
  Generic for: Clolar
• Diclofenac Sodium Topical Solution 2%
  Approved: May 15, 2017 - Actavis Laboratories, Inc.
  Generic for: Pennsaid
• Atomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
  Approved: May 30, 2017 - Apotex Inc.; Teva Pharmaceuticals USA Inc.; Aurobindo Pharma Limited; Glenmark Pharmaceuticals Limited
  Generic for: Strattera

April

• Tazarotene Cream 0.1%
  Approved: April 3, 2017 - Taro Pharmaceuticals USA, Inc.
  Generic for: Tazorac Cream 0.1% and Avage Cream 0.1%
• Dexlansoprazole Delayed-Release Capsules 60mg
  Approved: April 19, 2017 - Par Pharmaceutical, Inc.
  Generic for: Dexilant
• Prednisone Delayed-Release Tablets 1 mg, 2 mg and 5 mg
  Approved: April 25, 2017 - Actavis Pharma, Inc.
  Generic for: Rayos
• Ezetimibe and Simvastatin Tablets 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
  Approved: April 26, 2017 - Dr. Reddy's Laboratories Limited; Impax Laboratories, Inc.; Watson Laboratories, Inc.
  Generic for: Vytorin
• Vigabatrin for Oral Solution 500 mg/packet
  Approved: April 27, 2017 - Par Pharmaceutical Inc.
  Generic for: Sabril for Oral Solution

March

• Zileuton Extended Release Tablets 600 mg
  Approved: March 17, 2017 - Pack Pharmaceuticals, LLC
  Generic for: Zyflo CR
• Melphalan Tablets 2 mg
  Approved: March 22, 2017 - Alvogen Malta Operations Ltd.
  Generic for: Alkeran Tablets
• Silodosin Capsules 4 mg and 8 mg
  Approved: March 31, 2017 - Sandoz Inc.
  Generic for: Rapaflo

February

• Cefixime for Oral Suspension USP, 500 mg/5 mL
  Approved: February 6, 2017 - Belcher Pharmaceuticals, LLC
  Generic for: Suprax for Oral Suspension, 500 mg/5 mL
• Logilia (Ulipristal Acetate) Tablets 30 mg
  Approved: February 13, 2017 - Teva Pharmaceuticals USA, Inc.
  Generic for: Ella
• Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution 17.5 g/3.13 g/1.6 g per 6 ounces
  Approved: February 23, 2017 - Lupin Inc.
  Generic for: Suprep Bowel Prep Kit

January

• Sodium Oxybate Oral Solution 500 mg/mL
  Approved: January 17, 2017 - West-Ward Pharmaceuticals Corp.
  Generic for: Xyrem
• Desoximetasone Topical Spray 0.25%
  Approved: January 20, 2017 - Perrigo Company plc
  Generic for: Topicort Spray
• Dalfampridine Extended Release Tablets 10mg
  Approved: January 23, 2017 - Aurobindo Pharma Limited; Actavis Inc.
  Generic for: Ampyra
• Donepezil Hydrochloride and Memantine Hydrochloride Extended-Release Capsules 10 mg/ 14 mg and 10 mg/ 28 mg
  Approved: January 27, 2017 - Amneal Pharmaceuticals LLC
  Generic for: Namzaric

December

• Pitavastatin Calcium Tablets 1 mg (base), 2 mg (base), and 4 mg (base)
  Approved: December 20, 2016 - Aurobindo Pharma Ltd.
  Generic for: Livalo
• Lopinavir and Ritonavir Oral Solution 80 mg / 20 mg per mL
  Approved: December 27, 2016 - Silarx Pharmaceuticals Inc.
  Generic for: Kaletra Oral Solution

November

• Quetiapine Fumarate Extended-Release Tablets 400 mg
  Approved: November 1, 2016 - Accord Healthcare Inc.
  Generic for: Seroquel XR 400 mg
• Iloperidone Tablets 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
  Approved: November 28, 2016 - Inventia Healthcare Private Limited
  Generic for: Fanapt
• Dexmethylphenidate Hydrochloride Extended-Release Capsules 25 mg and 35 mg
  Approved: November 30, 2016 - Par Pharmaceutical, Inc.
  Generic for: Focalin XR

October

• Ribavirin for Inhalation Solution USP, 6 g/vial
  Approved: October 6, 2016 - Navinta LLC
  Generic for: Virazole
• Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets 3 mg/ 0.03 mg/ 0.451 mg and 0.451 mg
  Approved: October 11, 2016 - Watson Laboratories, Inc.
  Generic for: Safyral
• Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and and Levomefolate Calcium Tablets 3 mg/ 0.02mg/ 0.451 mg and 0.451 mg
  Approved: October 11, 2016 - Watson Laboratories, Inc.
  Generic for: Beyaz
• Olmesartan Medoxomil Tablets 5 mg, 20 mg and 40 mg
  Approved: October 26, 2016 - Mylan Pharmaceuticals Inc.
  Generic for: Benicar
• Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/ 12.5 mg, 40 mg/ 12.5 mg, and 40 mg/ 25 mg
  Approved: October 26, 2016 - Mylan Pharmaceuticals Inc.
  Generic for: Benicar HCT
• Amlodipine and Olmesartan Medoxomil Tablets 5 mg/ 20 mg, 5 mg/ 40 mg, 10 mg/ 20 mg, and 10 mg/ 40 mg
  Approved: October 26, 2016 - Macleods Pharmaceuticals Limited; Teva Pharmaceuticals USA, Inc.
  Generic for: Azor
• Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets 20 mg/ 5 mg/ 12.5 mg, 40 mg/ 5 mg/ 12.5 mg, 40 mg/ 5 mg/ 25 mg, 40 mg/ 10 mg/ 12.5 mg, and 40 mg/ 10 mg/ 25 mg
  Approved: October 26, 2016 - Par Pharmaceutical, Inc.; Torrent Pharmaceuticals Limited
  Generic for: Tribenzor

September

• Abacavir Oral Solution 20 mg/mL
  Approved: September 26, 2016 - Hetero Labs Limited Unit III
  Generic for: Ziagen Oral Solution
• Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg
  Approved: September 26, 2016 - Lupin Limited; Mylan Pharmaceuticals, Inc.; Sun Pharma Global FZE
  Generic for: Namenda XR

August

• Zolpidem Tartrate Sublingual Tablets 5 mg and 10 mg
  Approved: August 1, 2016 - Par Pharmaceutical, Inc.
  Generic for: Edluar
• Oseltamivir Phosphate Capsules 30 mg, 45 mg, 75 mg
  Approved: August 3, 2016 - Natco Pharma Limited
  Generic for: Tamiflu
• Doxylamine Succinate and Pyridoxine Hydrochloride Delayed Release Tablets 10 mg/10 mg
  Approved: August 19, 2016 - Actavis Pharma, Inc.
  Generic for: Diclegis

July

• Omeprazole and Sodium Bicarbonate Capsules 20 mg/1100 mg
  Approved: July 15, 2016 - Perrigo Company; Par Pharmaceutical Inc.; Actavis Pharma, Inc.
  Generic for: Zegerid OTC
• Nilutamide Tablets 150 mg
  Approved: July 15, 2016 - ANI Pharmaceuticals, Inc.
  Generic for: Nilandron
• Valganciclovir for Oral Solution 50 mg/mL
  Approved: July 18, 2016 - Actavis Pharma, Inc.
  Generic for: Valcyte for Oral Solution

June

• Dofetilide Capsules 125 mcg, 250 mcg and 500 mcg
  Approved: June 6, 2016 - Mayne Pharma
  Generic for: Tikosyn
• Fosaprepitant Dimeglumine Injection 150mg (base)/vial
  Approved: June 9, 2016 - Fresenius Kabi USA
  Generic for: Emend for Injection
• Dasatinib Tablets 20mg, 50mg, 70mg and 100mg
  Approved: June 10, 2016 - Apotex, Inc.
  Generic for: Sprycel
• Levoleucovorin for Injection 50 mg/vial
  Approved: June 16, 2016 - Eurohealth International Sarl
  Generic for: Fusilev
• Fenofibrate Tablets USP, 40 mg and 120 mg
  Approved: June 23, 2016 - Mylan Pharmaceuticals Inc.
  Generic for: Fenoglide
• Ethacrynic Acid Tablets USP, 25 mg
  Approved: June 30, 2016 - Edenbridge Pharmaceuticals, LLC
  Generic for: Edecrin

May

• Diclofenac Potassium for Oral Solution 50 mg
  Approved: May 2, 2016 - Par Formulations Private Limited
  Generic for: Cambia For Oral Solution
• Estradiol Valerate and Estradiol Valerate/Dienogest Tablets 3 mg, 2 mg/2 mg, 2 mg/3 mg and 1 mg
  Approved: May 6, 2016 - Watson Laboratories, Inc.
  Generic for: Natazia
• Rufinamide Tablets 200 mg and 400 mg
  Approved: May 16, 2016 - Roxane Laboratories, Inc.; Glenmark Pharmaceuticals Inc., USA; Mylan Pharmaceuticals Inc.
  Generic for: Banzel
• Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg
  Approved: May 23, 2016 - Mylan Pharmaceuticals, Inc.
  Generic for: Doxteric
• Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate Tablets 1 mg/0.02 mg and 75 mg
  Approved: May 24, 2016 - Lupin Pharmaceuticals, Inc.
  Generic for: Minastrin 24 Fe
• Febuxostat Tablets 40 mg and 80 mg
  Approved: May 24, 2016 - Sun Pharma Global FZE
  Generic for: Uloric

April

• Rosiglitazone Maleate and Glimeperide Tablets 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg and 8 mg/8 mg
  Approved: April 1, 2016 - Teva Pharmaceuticals USA, Inc.
  Generic for: Avandaryl
• Flurandrenolide Cream USP, 0.05%
  Approved: April 13, 2016 - Teligent Pharma, Inc.
  Generic for: Cordran SP Cream
• Fosamprenavir Calcium Tablets 700 mg
  Approved: April 15, 2016 - Mylan Pharmaceuticals, Inc.
  Generic for: Lexiva Tablets
• Lacosamide Oral Solution 10 mg/mL
  Approved: April 28, 2016 - Amneal Pharmaceuticals
  Generic for: Vimpat Oral Solution
• Lacosamide Tablets 50 mg, 100 mg, 150 mg and 200 mg
  Approved: April 28, 2016 - Actavis Pharma, Inc.; MSN Laboratories; Alembic Pharmaceuticals Limited; Aurobindo Pharma Limited; Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
  Generic for: Vimpat
• Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg
  Approved: April 29, 2016 - Watson Pharmaceuticals Inc.
  Generic for: Crestor

March

• Oxiconazole Nitrate Cream 1%
  Approved: March 7, 2016 - Taro Pharmaceuticals USA, Inc.
  Generic for: Oxistat Cream
• Sildenafil Citrate Tablets 25 mg (base), 50 mg (base), 100 mg (base)
  Approved: March 9, 2016 - Teva Pharmaceuticals USA, Inc.
  Generic for: Viagra
• Diclofenac Sodium Topical Gel 1%
  Approved: March 18, 2016 - Amneal Pharmaceuticals LLC
  Generic for: Voltaren Gel
• Mometasone Furoate Nasal Spray 0.05 mg base/spray
  Approved: March 22, 2016 - Apotex, Inc.
  Generic for: Nasonex
• Bendamustine Hydrochloride for Injection 25 mg/vial and 100 mg/vial
  Approved: March 24, 2016 - Glenmark Pharmaceuticals Inc., USA; Innopharma, Inc.
  Generic for: Treanda
• Daptomycin for Injection 500 mg/vial
  Approved: March 24, 2016 - Teva Pharmaceuticals USA, Inc.
  Generic for: Cubicin
• Ibuprofen Lysine Injection 20 mg (base)/2 mL
  Approved: March 30, 2016 - Exela Pharma Sciences
  Generic for: NeoProfen

February

• Efavirenz Tablets 600 mg
  Approved: February 17, 2016 - Mylan Pharmaceuticals Inc.
  Generic for: Sustiva
• Carbidopa Tablets 25 mg
  Approved: February 17, 2016 - Edenbridge Pharmaceuticals LLC
  Generic for: Lodosyn
• Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray
  Approved: February 19, 2016 - Lannett Holdings, Inc.
  Generic for: Imitrex Nasal Spray
• Diclofenac Potassium Capsules 25 mg
  Approved: February 23, 2016 - Bionpharma Inc.
  Generic for: Zipsor
• Sodium Phenylacetate and Sodium Benzoate Injection 10%/10%
  Approved: February 24, 2016 - Ailex Pharmaceutical Pvt Ltd.
  Generic for: Ammonul
• Fluticasone Propionate Nasal Spray USP, 50 mcg/spray
  Approved: February 29, 2016 - Apotex Corp.
  Generic for: Flonase Allergy Relief

January

• Naftifine Hydrochloride Cream 2%
  Approved: January 6, 2016 - Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Naftin Cream
• Deferasirox Tablets For Oral Suspension 125 mg, 250 mg and 500 mg
  Approved: January 26, 2016 - Actavis Elizabeth, LLC
  Generic for: Exjade
• Milnacipran Hydrochloride Tablets 12.5 mg, 25 mg, 50 mg and 100 mg
  Approved: January 27, 2016 - Liberty Pharma, Inc.
  Generic for: Savella

December

• Imatinib Mesylate Tablets 100 mg (base) and 400 mg (base)
  Approved: December 3, 2015 - Sun Pharmaceutical Industries Ltd.
  Generic for: Gleevec
• Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
  Approved: December 7, 2015 - USV North America, Inc.; Apotex, Inc.; Novel Laboratories, Inc.; Zach System S.P.A.
  Generic for: Patanol Ophthalmic Solution
• Fesoterodine Fumarate Extended-Release Tablets 4 mg and 8 mg
  Approved: December 10, 2015 - Alkem Laboratories Limited
  Generic for: Toviaz
• Busulfan Injection 6 mg/mL
  Approved: December 22, 2015 - Pharmaforce, Inc.
  Generic for: Busulfex
• Neostigmine Methylsulfate Injection USP 5 mg/10 mL and 10 mg/10 mL
  Approved: December 28, 2015 - Eurohealth International Sarl
  Generic for: Bloxiverz

November

• Mesalamine Rectal Suppository 1000 mg
  Approved: November 24, 2015 - Mylan Pharmaceuticals Inc.
  Generic for: Canasa

October

• Palonosetron Hydrochloride Injection 0.25 mg (base)/5 mL and 0.75 mg (base)/1.5 mL
  Approved: October 13, 2015 - Teva Pharmaceuticals USA Inc.; Sandoz Inc.
  Generic for: Aloxi Injection
• Memantine Hydrochloride Oral Solution 2 mg/mL
  Approved: October 13, 2015 - Macleods Pharmaceuticals Limited; Silarx Pharmaceuticals, Inc.
  Generic for: Namenda Oral Solution
• Itraconazole Oral Solution 10 mg/mL
  Approved: October 30, 2015 - Amneal Pharmaceuticals
  Generic for: Sporanox Oral Solution

September

• Rivastigmine Transdermal System 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours
  Approved: September 3, 2015 - Alvogen Pine Brook, Inc.
  Generic for: Exelon Patch
• Guaifenesin Extended-Release Tablets 1200 mg
  Approved: September 3, 2015 - Actavis Laboratories FL, Inc.
  Generic for: Mucinex Maximum Strength
• Balsalazide Disodium Tablets 1.1 gram
  Approved: September 8, 2015 - Par Pharmaceutical, Inc.
  Generic for: Giazo
• Fluvasatin Sodium Extended Release Tablets 80 mg
  Approved: September 10, 2015 - Mylan Pharmaceuticals Inc.
  Generic for: Lescol XL
• Clozapine Orally Disintegrating Tablets 25 mg and 100 mg
  Approved: September 15, 2015 - Mylan Pharmaceuticals Inc.
  Generic for: Fazaclo ODT
• Pimozide Tablets USP, 1 mg and 2 mg
  Approved: September 28, 2015 - Par Pharmaceutical, Inc.
  Generic for: Orap
• Adapalene and Bezoyl Peroxide Gel 0.1%/2.5%
  Approved: September 30, 2015 - Actavis Mid Atlantic, LLC
  Generic for: Epiduo

August

• Paliperidone Extended Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg
  Approved: August 3, 2015 - Actavis Laboratories FL, Inc.
  Generic for: Invega
• Testosterone Topical Gel 1.62%
  Approved: August 4, 2015 - Perrigo Israel Pharmaceuticals Ltd
  Generic for: Androgel
• Testosterone Topical Gel 10 mg per pump actuation
  Approved: August 5, 2015 - Actavis Laboratories UT, Inc.
  Generic for: Fortesta Gel
• Tretinoin Gel USP, 0.05%
  Approved: August 13, 2015 - Spear Pharmaceuticals
  Generic for: Atralin Gel
• Tetrabenazine Tablets 12.5 mg and 25 mg
  Approved: August 17, 2015 - Sun Pharma Global FZE
  Generic for: Xenazine
• Hydroxyprogesterone Caproate Injection USP 250 mg/mL (1.25 g/5 mL vials)
  Approved: August 24, 2015 - McGuff Pharmaceuticals, Inc.
  Generic for: Delalutin Injection
• Guaifenesin and Dextromethorphan Hydrobromide Extended Release Tablets 600 mg/30 mg and 1200 mg/60 mg
  Approved: August 31, 2015 - Activis Laboratories FL Inc.
  Generic for: Mucinex DM

July

• Almotriptan Malate Tablets 6.25 mg (base) and 12.5 mg (base)
  Approved: July 7, 2015 - Teva Pharmaceuticals USA Inc.
  Generic for: Axert
• Travoprost Ophthalmic Solution USP (Ionic Buffered Solution) 0.004%
  Approved: July 10, 2015 - Apotex Inc.
  Generic for: Travatan Z
• Olopatadine Hydrochloride Ophthalmic Solution 0.2% (base)
  Approved: July 13, 2015 - Barr Labs Inc.
  Generic for: Pataday
• Bivalirudin Injection 250 mg/vial
  Approved: July 14, 2015 - Hospira Inc.
  Generic for: Angiomax
• Metformin Hydrochloride and Repaglinide Tablets 500 mg/1 mg and 500 mg/2 mg
  Approved: July 15, 2015 - Lupin Pharmaceuticals, Inc.
  Generic for: PrandiMet
• Linezolid Injection 200 mg/100 mL and 600 mg/300 mL
  Approved: July 16, 2015 - Sandoz, Inc.
  Generic for: Zyvox Injection
• Ethacrynate Sodium for Injection USP, 50 mg/vial
  Approved: July 29, 2015 - Par Sterile Products, LLC
  Generic for: Edecrin
• Omeprazole Magnesium Delayed Release Tablets (OTC) 20.6 mg (20 mg base)
  Approved: July 30, 2015 - Perrigo R&D Company
  Generic for: Prilosec OTC

June

• Zolpidem Tartrate Sublingual Tablets 1.75 mg and 3.5 mg
  Approved: June 3, 2015 - Novel Laboratories,Inc.
  Generic for: Intermezzo
• Linezolid for Oral Suspension 100 mg/5 mL
  Approved: June 3, 2015 - Roxane Laboratories, Inc.
  Generic for: Zyvox for Oral Suspension
• Eptifibatide Injection 75 mg/100 mL
  Approved: June 5, 2015 - Teva Pharmaceuticals USA Inc.
  Generic for: Integrilin
• Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
  Approved: June 12, 2015 - Actavis Mid Atlantic LLC
  Generic for: Ziana
• Gemifloxacin Mesylate Tablets 320 mg (base)
  Approved: June 15, 2015 - Orchid Healthcare
  Generic for: Factive
• Clindamycin Phosphate and Benzyl Peroxide Gel 1.2%/2.5%
  Approved: June 19, 2015 - Actavis Laboratories, Inc.
  Generic for: Acanya
• Ezetimibe Tablets 10 mg
  Approved: June 26, 2015 - Glenmark Pharmaceuticals, Ltd.
  Generic for: Zetia
• Desvenlafaxine Succinate Extended-Release Tablets 50 mg and 100 mg
  Approved: June 29, 2015 - Alembic Pharmaceuticals Ltd.; Lupin Pharmaceuticals Inc.; Sandoz Inc.; Mylan Pharmaceuticals Inc.
  Generic for: Pristiq

May

• Alosetron Hydrochloride Tablets 0.5 mg (base) and 1 mg (base)
  Approved: May 4, 2015 - Roxane Laboratories, Inc.
  Generic for: Lotronex
• Linezolid Tablets 600 mg
  Approved: May 18, 2015 - Teva Pharmaceuticals USA Inc.
  Generic for: Zyvox Tablets
• Risedronate Sodium Delayed Release Tablets 35 mg
  Approved: May 18, 2015 - Teva Pharmaceuticals USA, Inc.
  Generic for: Atelvia
• Tigecycline Injection 50 mg/vial
  Approved: May 27, 2015 - Sandoz Inc.
  Generic for: Tygacil
• Moxifloxacin Hydrochloride Ophthalmic Solution 0.5% (base)
  Approved: May 28, 2015 - Lupin Ltd.
  Generic for: Moxeza
• Estradiol Vaginal Tablets 10 mcg
  Approved: May 29, 2015 - Amneal Pharmaceuticals
  Generic for: Vagifem

April

• Sildenafil Citrate Intravenous Solution 10 mg (base)/12.5 mL
  Approved: April 1, 2015 - Aurobindo Pharma Ltd.
  Generic for: Revatio Injection
• Triamcinolone Acetonide Topical Spray 0.147 mg/g
  Approved: April 13, 2015 - Perrigo Company plc
  Generic for: Kenalog Spray
• Nebivolol Hydrochloride Tablets 2.5 mg (base), 5 mg (base), 10 mg (base) and 20 mg (base)
  Approved: April 16, 2015 - Amerigen Pharmaceuticals, Ltd.
  Generic for: Bystolic
• Glatiramer Acetate Injection 20 mg/mL, packaged in 1 mL prefilled syringe
  Approved: April 16, 2015 - Sandoz, Inc.
  Generic for: Copaxone
• Fluorouracil Cream 0.5%
  Approved: April 20, 2015 - Spear Pharmaceuticals
  Generic for: Carac
• Vardenafil Hydrochloride Orally Disintegrating Tablets 10 mg
  Approved: April 22, 2015 - Watson Laboratories, Inc.
  Generic for: Staxyn
• Aripiprazole Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
  Approved: April 28, 2015 - Torrent Pharma, Inc.
  Generic for: Abilify

March

• Levoleucovorin Calcium Injection 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single Use Vials
  Approved: March 9, 2015 - Company: Sandoz, Inc.
  Generic for: Fusilev
• Darifenacin Hydrobromide Extended Release Tablets 7.5 mg (base) and 15 mg (base)
  Approved: March 13, 2015 - Company: Anchen Pharmaceuticals, Inc.
  Generic for: Enablex
• Tenofovir Disoproxil Fumarate Tablets 300 mg
  Approved: March 18, 2015 - Company: Teva Pharmaceuticals USA
  Generic for: Viread
• Molindone Hydrochloride Tablets 5 mg, 10 mg and 25 mg
  Approved: March 23, 2015 - CorePharma
  Generic for: Moban
• Tolcapone Tablets 100 mg
  Approved: March 26, 2015 - Par Pharmaceutical
  Generic for: Tasmar

February

• Bimatoprost Ophthalmic Solution 0.03%
  Approved: February 20, 2015 - Lupin Pharmaceuticals, Inc.
  Generic for: Lumigan
• Miglitol Tablets 25 mg, 50 mg and 100 mg
  Approved: February 24, 2015 - Orient Pharma Co., Ltd.
  Generic for: Glyset

January

• Ritonavir Tablets USP 100 mg
  Approved: January 15, 2015 - Roxane Laboratories, Inc.
  Generic for: Norvir
• Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg and 40 mg
  Approved: January 26, 2015 - Ivax Pharmaceuticals, Inc.
  Generic for: Nexium Delayed-Release Capsules

December

• Bimatoprost Ophthalmic Solution 0.03%
  Approved: December 1, 2014 - Apotex, Inc.
  Generic for: Latisse
• Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day (Twice-Weekly)
  Approved: December 19, 2015 - Mylan Technologies, Inc.
  Generic for: Vivelle-Dot
• Desvenlafaxine Succinate Extended-Release Tablets 50 mg and 100 mg
  Approved: December 31, 2014 - Roxane Laboratories, Inc.
  Generic for: Pristiq

November

• Valganciclovir Hydrochloride Tablets 450 mg (base)
  Approved: November 4, 2014 - Endo Pharmaceuticals Inc.; Dr. Reddy's Laboratories Limited
  Generic for: Valcyte

October

• Olopatadine Hydrochloride Nasal Spray 0.665 mg/Spray
  Approved: October 8, 2014 - Apotex, Inc.
  Generic for: Patanase
• Ivermectin Tablets 3 mg
  Approved: October 27, 2014 - Edenbridge Pharmaceuticals, LLC
  Generic for: Stromectol

September

• Moxifloxacin Hydrochloride Ophthalmic Solution 0.5% (base)
  Approved: September 4, 2014 - Lupin Pharmaceuticals, Inc.
  Generic for: Vigamox
• Tacrolimus Topical Ointment 0.03% and 0.1%
  Approved: September 9, 2014 - Fougera Pharmaceuticals Inc.
  Generic for: Protopic
• Daptomycin Injection 500 mg/vial
  Approved: September 12, 2014 - Hospira, Inc.
  Generic for: Cubicin

August

• Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg (base) and 10 mg (base)
  Approved: August 12, 2014 - Novel Labs, Inc.
  Generic for: Metozolv ODT
• Bexarotene Capsules 75 mg
  Approved: August 12, 2014 - Banner Pharmacaps
  Generic for: Targretin
• Dexmedetomidine Hydrochloride Injection 200 mcg (base)/ 2 mL
  Approved: August 15, 2014 - Mylan Institutional LLC; Par Pharmaceutical, Inc.
  Generic for: Precedex
• Entecavir Tablets 0.5 mg and 1 mg
  Approved: August 26, 2014 - Teva Pharmaceuticals USA Inc.
  Generic for: Baraclude
• Frovatriptan Succinate Tablets 2.5 mg (base)
  Approved: August 28, 2014 - Mylan Pharmaceuticals Inc.
  Generic for: Frova

June

• Risedronate Sodium Tablets 75 mg and 150 mg
  Approved: June 10, 2014 - Apotex, Inc.; Mylan Pharmaceuticals, Inc.; Sun Pharma Global FZE
  Generic for: Actonel 75 mg and 150 mg
• Erlotinib Hydrochloride Tablets 25 mg, 100 mg and 150 mg
  Approved: June 11, 2014 - Mylan Pharmaceuticals, Inc.
  Generic for: Tarceva
• Valsartan Tablets 40 mg, 80 mg, 160 mg and 320 mg
  Approved: June 26, 2014 - Ohm Laboratories, Inc.
  Generic for: Diovan

May

• Metformin Hydrochloride and Rosiglitazone Maleate Tablets 500 mg/2 mg (base), 500 mg/4 mg (base), 1000 mg/2 mg (base) and 1000 mg/4 mg (base)
  Approved: May 7, 2014 - Teva Pharmaceuticals, Inc.
  Generic for: Avandamet
• Budesonide Nasal Spray 0.032 mg/inhalation
  Approved: May 12, 2014 - Apotex, Inc.
  Generic for: Rhinocort Aqua
• Hydromorphone Hydrochloride Extended Release Tablets 8 mg, 12 mg and 16 mg
  Approved: May 12, 2014 - Actavis plc
  Generic for: Exalgo
• Diclofenac Sodium Topical Solution 1.5%
  Approved: May 27, 2014 - Apotex, Inc.
  Generic for: Pennsaid
• Atovaquone and Proguanil Hydrochloride Tablets 62.5 mg/25 mg and 250 mg/100 mg
  Approved: May 27, 2014 - Mylan Pharmaceuticals, Inc.
  Generic for: Malarone
• Celecoxib Capsules 50 mg, 100 mg, 200 mg and 400 mg
  Approved: May 30, 2014 - Teva Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc. (50 mg)
  Generic for: Celebrex

April

• Solifenacin Succinate Tablets 5 mg and 10 mg
  Approved: April 2, 2014 - Teva Pharmaceuticals, Inc.
  Generic for: Vesicare
• Clonidine Hydrochloride Extended Release Tablets 0.1 mg and 0.2 mg
  Approved: April 2, 2014 - Anchen Pharmaceuticals, Inc.
  Generic for: Jenloga
• Nevirapine Extended Release Tablets 400 mg
  Approved: April 3, 2014 - Apotex Inc.; Sandoz Inc.
  Generic for: Viramune XR
• Omega-3-Acid Ethyl Esters Capsules 1 gram
  Approved: April 7, 2014 - Teva Pharmaceuticals, Inc.
  Generic for: Lovaza
• Norelgestromin and Ethinyl Estradiol Transdermal System 150 mcg / 35 mcg (per day)
  Approved: April 16, 2014 - Mylan Pharmaceuticals Inc.
  Generic for: Ortho Evra
• Atazanavir Sulfate Capsules 100 mg (base), 150 mg (base), 200 mg (base) and 300 mg (base)
  Approved: April 22, 2014 - Teva Pharmaceuticals, Inc.
  Generic for: Reyataz
• Norethindrone and Ethinyl Estradiol and Ferrous Fumarate Chewable Tablets 0.8 mg / 0.025 mg
  Approved: April 23, 2014 - Famy Care Limited
  Generic for: Generess Fe

March

• Raloxifene Hydrochloride Tablets 60 mg
  Approved: March 4, 2014 - Teva Pharmaceuticals, Inc.
  Generic for: Evista
• Oxybutynin Transdermal System 3.9 mg/24 hr
  Approved: March 4, 2014 - Barr Laboratories Inc.
  Generic for: Oxytrol
• Carbidopa Tablets 25 mg
  Approved: March 10, 2014 - Amerigen Pharmaceuticals Inc.
  Generic for: Lodosyn
• Atovaquone Oral Suspension 750 mg/5 mL
  Approved: March 18, 2014 - Amneal Pharmaceuticals LLC
  Generic for: Mepron Suspension

February

• Pramipexole Dihydrochloride Extended-Release Tablets 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg
  Approved: February 6, 2014 - Anchen Pharmaceuticals, Inc.
  Generic for: Mirapex ER
• Ketorolac Tromethamine Ophthalmic Solution/Drops 0.45%
  Approved: February 10, 2014 - Akorn, Inc.
  Generic for: Acuvail
• Ibandronate Sodium Injection 3 mg (base)/3 mL
  Approved: February 14, 2014 - Sun Pharmaceutical Industries Ltd.
  Generic for: Boniva Injection
• Moxifloxacin Hydrochloride Tablets 400 mg (base)
  Approved: February 18, 2014 - Teva Pharmaceuticals USA Inc.
  Generic for: Avelox
• Rifabutin Capsules 150 mg
  Approved: February 24, 2014 - Lupin Pharmaceuticals, Inc.
  Generic for: Mycobutin
• Hydrochlorothiazide and Telmisartan Tablets 12.5 mg/40 mg, 12.5 mg/80 mg and 25 mg/80 mg
  Approved: February 25, 2014 - Mylan Pharmaceuticals Inc.; Torrent Pharmaceuticals Limited; Alembic Pharmaceuticals Limited
  Generic for: Micardis HCT
• Dutasteride and Tamsulosin Capsules 0.5 mg/0.4 mg
  Approved: February 26, 2014 - Anchen Pharmaceuticals, Inc.
  Generic for: Jalyn

January

• Lamivudine Tablets (HBV) 100 mg
  Approved: January 2, 2014 - Hetero Labs Limited; Apotex Corp.
  Generic for: Epivir-HBV
• Telmisartan Tablets 20 mg, 40 mg and 80 mg
  Approved: January 8, 2014 - Watson Laboratories, Inc.
  Generic for: Micardis
• Amlodipine Besylate and Telmisartan Tablets 5 mg (base)/40 mg, 10 mg (base)/40 mg, 5 mg (base)/80 mg and 10 mg (base)/80 mg
  Approved: January 8, 2014 - Lupin Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Inc.
  Generic for: Twynsta
• Sirolimus Tablets 0.5 mg, 1 mg and 2 mg
  Approved: January 8, 2014 - Zydus Pharmaceuticals (USA) Inc.
  Generic for: Rapamune
• Mycophenolic Acid Delayed-Release Tablets 180 mg and 360 mg
  Approved: January 8, 2014 - Mylan Pharmaceuticals, Inc.
  Generic for: Myfortic
• Doxercalciferol Capsules 1 mcg and 2.5 mcg
  Approved: January 14, 2014 - Roxane Laboratories, Inc.
  Generic for: Hectorol
• Fluocinonide Cream USP, 0.1%
  Approved: January 14, 2014 - Perrigo Israel Pharmaceuticals, Ltd.
  Generic for: Vanos
• Bromfenac Ophthalmic Solution 0.09% (Once-A-Day)
  Approved: January 22, 2014 - Hi-Tech Pharmacal Co., Inc.
  Generic for: Bromday
• Sunitinib Malate Capsules 12.5 mg (base), 25 mg (base), 37.5 mg (base) and 50 mg (base)
  Approved: January 30, 2014 - Mylan Pharmaceuticals Inc.
  Generic for: Sutent

December

• Abacavir Sulfate, Lamivudine and Zidovudine Tablets 300 mg (base)/150 mg/300 mg
  Approved: December 5, 2013 - Lupin Pharmaceuticals, Inc.
  Generic for: Trizivir
• Duloxetine Hydrochloride Delayed Release Capsules 20 mg (base), 30 mg (base) and 60 mg (base)
  Approved: December 11, 2013 - Lupin Pharmaceuticals, Inc.; Teva Pharmaceuticals USA Inc.; Torrent Pharmaceuticals Limited; Sun Pharma Global FZE; Dr. Reddy's Laboratories Limited; Aurobindo Pharma Limited
  Generic for: Cymbalta
• Diclofenac Sodium Topical Solution 1.5% (w/w)
  Approved: December 26, 2013 - Paddock Laboratories LLC
  Generic for: Pennsaid Topical Solution
• Dexlansoprazole Delayed-Release Capsules 60 mg
  Approved: December 26, 2013 - Par Pharmaceutical, Inc.
  Generic for: Dexilant

November

• Finasteride Tablets USP, 1 mg
  Approved: November 5, 2013 - Actavis Totowa LLC; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Accord Healthcare, Inc.; Aurobindo Pharma Limited
  Generic for: Propecia
• Rabeprazole Sodium Delayed-Release Tablets 20 mg
  Approved: November 8, 2013 - Torrent Pharmaceuticals Limited; Lupin Limited; Mylan Pharmaceuticals Inc.; Teva Pharmaceuticals USA; Kremers Urban Pharmaceuticals, Inc.; Dr. Reddy's Laboratories Limited
  Generic for: AcipHex
• Dexmethylphenidate Hydrochloride Extended-Release Capsules 5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg
  Approved: November 18, 2013 - Intellipharmaceutics Corp.
  Generic for: Focalin XR
• Dexmethylphenidate Hydrochloride Extended-Release Capsules 25 mg, 30 mg, 35 mg and 40 mg
  Approved: November 19, 2013 - Teva Pharmaceuticals USA
  Generic for: Focalin XR

October

• Tobramycin Inhalation Solution 300 mg/5 mL
  Approved: October 10, 2013 - Teva Pharmaceuticals USA
  Generic for: Tobi
• Diclofenac Sodium Topical Gel 3%
  Approved: October 28, 2013 - Tolmar, Inc.
  Generic for: Solaraze
• Tolterodine Tartrate Extended-Release Capsules 2 mg and 4 mg
  Approved: October 31, 2014 - Mylan Pharmaceuticals, Inc.
  Generic for: Detrol LA

September

• Azacitidine Injection 100 mg/vial
  Approved: September 16, 2013 - Dr. Reddy's Laboratories, Ltd.
  Generic for: Vidaza
• Capecitabine Tablets 150 mg and 500 mg
  Approved: September 16, 2013 - Teva Pharmaceuticals USA
  Generic for: Xeloda
• Nitroglycerin Lingual Spray 400 mcg/spray; Packaged in 60 and 200 Metered Spray Containers
  Approved: September 20, 2013 - Perrigo Israel Pharmaceuticals, Ltd.
  Generic for: Nitrolingual
• Paricalcitol Capsules 1 mcg, 2 mcg and 4 mcg
  Approved: September 27, 2013 - Teva Pharmaceuticals USA
  Generic for: Zemplar Capsules
• Esomeprazole Magnesium and Naproxen Delayed Release Tablets 20 mg (base)/375 mg and 20 mg (base)/500 mg
  Approved: September 27, 2013 - Dr. Reddy's Laboratories, Ltd.
  Generic for: Vimovo
• Clonidine Hydrochloride Extended Release Tablets 0.1 mg and 0.2 mg
  Approved: September 30, 2013 - Anchen Pharmaceuticals, Inc.
  Generic for: Kapvay

August

• Ethinyl Estradiol and Norethindrone Tablets USP, 0.05 mg/1 mg
  Approved: August 8, 2013 - Famy Care Ltd.
  Generic for: Ovcon-50
• Dexmethylphenidate Hydrochloride Extended-Release Capsules 30 mg
  Approved: August 28, 2013 - Mylan Pharmaceuticals, Inc.
  Generic for: Focalin XR
• Gatifloxacin Ophthalmic Solution 0.5%
  Approved: August 28, 2013 - Lupin Ltd.
  Generic for: Zymaxid
• Adefovir Dipivoxil Tablets 10 mg
  Approved: August 29, 2013 - Sigmapharm Labs LLC
  Generic for: Hepsera
• Amoxicillin, Clarithromycin and Lansoprazole Capsules/Tablets/Capsules 500 mg/500 mg/30 mg
  Approved: August 30, 2013 - Teva Pharmaceuticals USA Inc.
  Generic for: Prevpac

July

• Rasagiline Mesylate Tablets 0.5 mg and 1 mg
  Approved: July 1, 2013 - Watson Laboratories, Inc.
  Generic for: Azilect
• Decitabine for Injection 50 mg
  Approved: July 11, 2013 - Dr. Reddy’s Laboratories Inc.
  Generic for: Dacogen
• Repaglinide Tablets 1 mg and 2 mg
  Approved: July 11, 2013 - Caraco Pharmaceutical Laboratories, Ltd.; Paddock Laboratories, Inc.
  Generic for: Prandin
• Lamotrigine Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg and 200 mg
  Approved: July 15, 2013 - Watson Laboratories, Inc.
  Generic for: Lamictal ODT
• Acamprosate Calcium Delayed-Release Tablets 333 mg
  Approved: July 16, 2013 - Glenmark Generics Inc., USA
  Generic for: Campral
• Tretinoin Gel USP, (Microspheres) 0.1%
  Approved: July 17, 2013 - Spear Pharmaceuticals, Inc.
  Generic for: Retin-A Micro
• Tretinoin Gel USP, 0.04%
  Approved: July 17, 2013 - Spear Pharmaceuticals, Inc.
  Generic for: Retin-A Micro Gel
• Fenofibric Acid Delayed-Release Capsules 45 mg and 135 mg
  Approved: July 18, 2013 - Anchen Pharmaceuticals, Inc.
  Generic for: Trilipix Delayed-Release Capsules
• Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg
  Approved: July 19, 2013 - Lupin Limited
  Generic for: Glumetza Tablets

June

• Riluzole Tablets 50 mg
  Approved: June 18, 2013 - Apotex, Inc.; Glenmark Generics Limited; Sun Pharmaceutical Industries Ltd.
  Generic for: Rilutek

May

• Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg
  Approved: May 3, 2013 - Sandoz Inc.
  Generic for: Atacand
• Zolmitriptan Tablets 2.5 mg and 5 mg
  Approved: May 15, 2013 - Apotex Corp.; Glenmark Generics; Mylan Pharmaceuticals, Inc.
  Generic for: Zomig Tablets
• Zolmitriptan Orally Disintegrating Tablets 2.5 mg and 5 mg
  Approved: May 15, 2013 - Apotex Corp.; Glenmark Generics
  Generic for: Zomig-ZMT Tablets
• Voriconazole for Suspension 200 mg/5 mL
  Approved: May 28, 2013 - Mylan Pharmaceuticals Inc.
  Generic for: Vfend for Oral Suspension

April

• Acyclovir Ointment 5%
  Approved: April 3, 2013 - Mylan Pharmaceuticals Inc.
  Generic for: Zovirax Ointment
• Acitretin Capsules 10 mg, 17.5 mg, 22.5 mg and 25 mg
  Approved: April 4, 2013 - Barr Laboratories Inc.; Teva Pharmaceuticals USA Inc.
  Generic for: Soriatane
• Prednisolone Sodium Phosphate Orally Disintegrating Tablets 10 mg (base), 15 mg (base) and 30 mg (base)
  Approved: April 10, 2013 - Mylan Pharmaceuticals, Inc.
  Generic for: Orapred ODT
• Omeprazole and Sodium Bicarbonate for Oral Suspension 20 mg/1680 mg per unit-dose packet and 40 mg/1680 mg per unit-dose packet
  Approved: April 19, 2013 - Par Pharmaceutical Inc.
  Generic for: Zegerid Powder for Oral Suspension

March

• Travoprost Ophthalmic Solution/Drops 0.004%
  Approved: March 1, 2013 - Par Pharmaceutical, Inc.
  Generic for: Travatan
• Zoledronic Acid Injection 4 mg (base)/5 mL
  Approved: March 4, 2013 - Sun Pharma Global FZE; Dr. Reddy's Laboratories Inc.; Actavis Inc.; Agila Specialties Private Limited
  Generic for: Zometa
• Desvenlafaxine Extended-Release Tablets 50 mg and 100 mg
  Approved: March 4, 2013 - Ranbaxy Pharmaceuticals Inc.
  Generic for: Pristiq
• Fluvoxamine Maleate Extended-Release Capsules 100 mg and 150 mg
  Approved: March 13, 2013 - Anchen Pharmaceuticals, Inc.
  Generic for: Luvox CR Capsules
• Esomeprazole Sodium for Injection 20 mg and 40 mg; single-use vials
  Approved: March 18, 2013 - Sun Pharma Global FZE
  Generic for: Nexium I.V. For Injection
• Mecamylamine Hydrochloride Tablets 2.5 mg
  Approved: March 19, 2013 - Nexgen Pharma, Inc.
  Generic for: Inversine
• Sodium Phenylbutyrate Powder 3 grams/teaspoonful; 250 grams/bottle
  Approved: March 22, 2013 - Sigmapharm Laboratories, LLC
  Generic for: Buphenyl Powder
• Fenofibric Acid Delayed-Release Capsules 45 mg and 135 mg
  Approved: March 25, 2013 - Mylan Pharmaceuticals, Inc.
  Generic for: Trilipix Delayed-Release Capsules
• Amlodipine Besylate and Valsartan Tablets 5 mg (base)/160 mg, 5 mg (base)/320mg, 10 mg (base)/160 mg and 10 mg (base)/320 mg
  Approved: March 28, 2013 - Par Pharmaceutical, Inc.
  Generic for: Exforge
• Zoledronic Acid Injection 5 mg (base)/100 mL (0.05 mg (base)/mL); single-use vials for I.V. administration
  Approved: March 29, 2013 - Emcure Pharmaceuticals Ltd.; Dr. Reddy's Laboratories Limited
  Generic for: Reclast Injection

February

• Doxorubicin Hydrochloride Liposomal Injection 20 mg/10 mL and 50 mg/25 mL
  Approved: February 4, 2013 - Sun Pharmaceutical Industries Ltd.
  Generic for: Doxil
• Mafenide Acetate Topical Solution 5%
  Approved: February 12, 2013 - Par Pharmaceutical, Inc.
  Generic for: Sulfamylon
• Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets 2 mg (base)/0.5 mg (base) and 8 mg (base)/2 mg (base)
  Approved: February 22, 2013 - Actavis Elizabeth LLC; Amneal Pharmaceuticals
  Generic for: Suboxone Tablets
• Alendronate Sodium Oral Solution 70 mg (base)/75 mL (Once Weekly)
  Approved: February 25, 2013 - Roxane Laboratories, Inc.
  Generic for: Fosamax Oral Solution
• Dexbrompheniramine Maleate and Pseudoephedrine Sulfate Extended-Release Tablets (OTC), 6 mg/120 mg
  Approved: February 27, 2013 - Avanthi Inc.
  Generic for: Drixoral Cold and Allergy Tablets

January

• Glimepiride and Pioglitazone Hydrochloride Tablets 2 mg/30 mg and 4 mg/30 mg
  Approved: January 4, 2013 - Sandoz Inc.
  Generic for: Duetact
• Betamethasone Dipropionate and Calcipotriene Ointment 0.064% / 0.005%
  Approved: January 14, 2013 - Tolmar, Inc.
  Generic for: Taclonex Ointment
• Morphine Sulfate Extended-Release Capsules USP, 30 mg, 45 mg, 60 mg, 75 mg, 90 mg and 120 mg
  Approved: January 16, 2013 - Actavis Elizabeth, LLC
  Generic for: Avinza Extended-Release Capsules
• Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
  Approved: January 18, 2013 - Dr. Reddy's Laboratories Limited
  Generic for: Children's Allegra Allergy & Allegra Hives
• Mupirocin Cream 2% (base)
  Approved: January 24, 2013 - Glenmark Generics Inc., USA
  Generic for: Bactroban Cream
• Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution USP 0.025%/0.3% (OTC)
  Approved: January 24, 2013 -Akorn Inc.
  Generic for: Visine-A Ophthamlic Solution
• Rosiglitazone Maleate Tablets 2 mg (base), 4 mg (base) and 8 mg (base)
  Approved: January 25, 2013 - Teva Pharmaceuticals USA Inc.
  Generic for: Avandia

December

• Candesartan Cilexetil and Hydrochlorothiazide Tablets 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mg (Mylan only)
  Approved: December 4, 2012 - Apotex Corp.; Mylan Pharmaceuticals Inc.
  Generic for: Atacand HCT
• Phenytoin Chewable Tablets USP, 50 mg
  Approved: December 26, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Dilantin Chewable Tablets
• Lamotrigine Extended-Release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg and 300 mg
  Approved: December 26, 2012 - Anchen Pharmaceuticals, Inc.
  Generic for: Lamictal XR
• Tranexamic Acid Tablets 650 mg
  Approved: December 27, 2012 - Watson Laboratories, Inc.
  Generic for: Lysteda
• Methylphenidate Hydrochloride Extended Release Tablets 27 mg, 36 mg and 54 mg
  Approved: December 28, 2012 - Mallinckrodt, Inc.
  Generic for: Concerta
• Rizatriptan Benzoate Tablets 5 mg (base) and 10 mg (base)
  Approved: December 31, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Glenmark Generics Inc., USA; Mylan Pharmaceuticals Inc.; Natco Pharma Limited; Sandoz Inc.; Sun Pharma Global Inc.; Teva Pharmaceuticals USA;
  Generic for: Maxalt
• Rizatriptan Benzoate Orally Disintegrating Tablets 5 mg (base) and 10 mg (base)
  Approved: December 31, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Maxalt-MLT

November

• Sildenafil Citrate Tablets 20 mg (base)
  Approved: November 6, 2012 - Apotex Corp.; Torrent Pharmaceuticals Limited; Watson Laboratories, Inc.; Dr. Reddy's Laboratories Limited
  Generic for: Revatio
• Betamethasone Valerate Aerosol Foam 0.12% (base)
  Approved: November 26, 2012 - Cobrek Pharmaceuticals, Inc.
  Generic for: Luxiq

October

• Guanfacine Hydrochloride Extended Release Tablets 1mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
  Approved: October 5, 2012 - Actavis Elizabeth LLC
  Generic for: Intuniv
• Trospium Chloride Extended Release Capsules 60 mg
  Approved: October 12, 2012 - Watson Laboratories, Inc.
  Generic for: Sanctura XR
• Griseofulvin Ultramicrosize Tablets USP, 125 mg and 250 mg
  Approved: October 22, 2012 - Sigmapharm Laboratories, LLC
  Generic for: Gris-PEG

September

• Valsartan and Hydrochlorothiazide Tablets USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg
  Approved: September 21, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Diovan HCT
• Aprepitant Capsules 40 mg, 80 mg and 125 mg
  Approved: September 24, 2012 - Sandoz Inc.
  Generic for: Emend
• Tolterodine Tartrate Tablets 1 mg and 2 mg
  Approved: September 25, 2012 - Apotex Corp.
  Generic for: Detrol
• Amlodipine Besylate, Hydrochlorothiazide and Valsartan Tablets 5 mg/12.5 mg/160 mg, 10 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg
  Approved: September 25, 2012 - Teva Pharmaceuticals USA Inc.
  Generic for: Exforge HCT
• Quinine Sulfate Capsules USP, 324 mg
  Approved: September 28, 2012 - Teva Pharmaceuticals, USA
  Generic for: Qualaquin
• Progesterone Capsules 100 mg and 200 mg
  Approved: September 28, 2012 - Sofgen Pharmaceuticals, LLC
  Generic for: Prometrium

August

• Montelukast Sodium Tablets 10 mg (base)
  Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Glenmark Generics; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals
  Generic for: Singulair Tablets
• Montelukast Sodium Chewable Tablets 4 mg (base) and 5 mg (base)
  Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals
  Generic for: Singulair Chewable Tablets
• Montelukast Sodium Granules 4 mg (base)/packet
  Approved: August 3, 2012 - Teva Pharmaceuticals Inc.
  Generic for: Singulair Granules
• Didanosine Chewable Tablets 100 mg, 150 mg and 200 mg
  Approved: August 14, 2012 - Aurobindo Pharma Limited
  Generic for: Videx Chewable Tablets
• Clobetasol Propionate Foam 0.05%
  Approved: August 14, 2012 - Perrigo Israel Pharmaceuticals, Ltd.
  Generic for: Olux E Foam
• Pioglitazone Hydrochloride Tablets 15 mg (base), 30 mg (base) and 45 mg (base)
  Approved: August 17, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Actos
• Mycophenolic Acid Delayed-Release Tablets 180 mg
  Approved: August 21, 2012 - Apotex Corp.
  Generic for: Myfortic
• Nedocromil Sodium Ophthalmic Solution 2%
  Approved: August 22, 2012 - Akorn, Inc.
  Generic for: Alocril
• Lidocaine Topical Patch 5%
  Approved: August 23, 2012 - Watson Pharmaceuticals, Inc.
  Generic for: Lidoderm
• Armodafinil Tablets 100 mg and 200 mg
  Approved: August 29, 2012 - Watson Laboratories, Inc.
  Generic for: Nuvigil
• Azelastine Hydrochloride Nasal Solution, (Nasal Spray) 0.15% (0.187 mg (base)/spray)
  Approved: August 31, 2012 - Apotex Inc.
  Generic for: Astepro

July

• Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
  Approved: July 3, 2012 - Lupin Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.
  Generic for: Lyrica
• Diclofenac Sodium and Misoprostol Delayed Release Tablets 50 mg/0.2 mg and 75 mg/0.2 mg
  Approved: July 9, 2012 - Watson Pharmaceuticals, Inc.
  Generic for: Arthrotec
• Levonorgestrel Tablets (Next Choice One Dose) 1.5 mg
  Approved: July 12, 2012 - Watson Pharmaceuticals, Inc.
  Generic for: Plan B One-Step
• Phenoxybenzamine Hydrochloride Capsules USP, 10 mg
  Approved: July 16, 2012 - Roxane Laboratories, Inc.
  Generic for: Dibenzyline
• Modafinil Tablets 100 mg and 200 mg
  Approved: July 16, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Provigil
• Entacapone Tablets 200 mg
  Approved: July 16, 2012 - Sun Pharma Global
  Generic for: Comtan
• Methylphenidate Hydrochloride Extended-Release Capsules (CD) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg
  Approved: July 19, 2012 - Teva Pharmaceuticals USA
  Generic for: Metadate CD
• Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL
  Approved: July 25, 2012 - Actavis Mid Atlantic
  Generic for: Allegra Oral Suspension

June

• Armodafinil Tablets 50 mg, 150 mg and 250 mg
  Approved: June 1, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Nuvigil
• Adapalene Gel 0.3%
  Approved: June 14, 2012 - Tolmar, Inc.
  Generic for: Differin Gel 0.3%
• Abacavir Sulfate Tablets 300 mg (base)
  Approved: June 18, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Ziagen
• Olanzapine and Fluoxetine Hydrochloride Capsules 25 mg (base)/6 mg (base), 25 mg (base)/12 mg (base), 50 mg (base)/6 mg (base) and 50 mg (base)/12 mg (base)
  Approved: June 19, 2012 - Teva Pharmaceuticals USA Inc.
  Generic for: Symbyax
• Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
  Approved: June 22, 2012 - Actavis Elizabeth LLC
  Generic for: Adderall XR
• Metformin Hydrochloride and Pioglitazone Hydrochloride Tablets 500 mg/15 mg (base) and 850 mg/15 mg (base)
  Approved: June 26, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Actoplus Met
• Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/5%
  Approved: June 26, 2012 - Perrigo Israel Pharmaceuticals Ltd.
  Generic for: Duac Topical Gel
• Linezolid Injection 200 mg/100 mL
  Approved: June 27, 2012 - Teva Pharmaceuticals USA Inc.
  Generic for: Zyvox Injection
• Cidofovir Injection 75 mg (base)/mL
  Approved: June 27, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Vistide

May

• Vardenafil Tablets 2.5 mg, 5 mg, 10 mg and 20 mg
  Approved: May 3, 2012 - Teva Pharmaceuticals USA
  Generic for: Levitra
• Carbidopa, Entacapone and Levodopa Tablets 25 mg/200 mg/100 mg and 37.5 mg/200 mg/150 mg
  Approved: May 10, 2012 - Sun Pharma Global FZE
  Generic for: Stalevo 100 and Stalevo 150
• Clopidogrel Tablets 75 mg (base) and 300 mg (base)
  Approved: May 17, 2012 - Apotex Inc.; Aurobindo Pharma Limited; Dr.Reddy's Laboratories Limited; Gate Pharmaceuticals; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Sun Pharma Global FZE; Teva Pharmaceuticals, USA Inc.; Torrent Pharmaceuticals Limited
  Generic for: Plavix
• Ropinirole Hydrochloride Extended-Release 2 mg (base), 4 mg (base), 6 mg (base), 8 mg (base) and 12 mg (base)
  Approved: May 17, 2012 - Actavis Elizabeth LLC
  Generic for: Requip XL
• Butoconazole Vaginal Cream 2%
  Approved: May 18, 2012 - Perrigo Israel
  Generic for: Gynazole-1
• Minocycline Hydrochloride Extended-Release Tablets 65 mg (base) and 115 mg (base)
  Approved: May 18, 2012 - Barr Laboratories, Inc.
  Generic for: Solodyn
• Lansoprazole Delayed-Release Capsules 15 mg (OTC)
  Approved: May 18, 2012 - Dr.Reddy's Laboratories Limited; Perrigo; Wockhardt Ltd.
  Generic for: Prevacid 24HR
• Nevirapine Tablets 200 mg
  Approved: May 22, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Camber Pharmaceuticals, Inc.; Cipla Limited; Micro Labs Limited; Mylan Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Sciegen Pharmaceuticals
  Generic for: Viramune Tablets
• Nevirapine Oral Suspension 50 mg/5 mL
  Approved: May 22, 2012 - Aurobindo Pharma Limited
  Generic for: Viramune Oral Suspension
• Dextromethorphan Polistirex Extended Release Suspension eq 30 mg dextromethorphan hydrobromide /5 mL
  Approved: May 25, 2012 - Tris Pharma, Inc.
  Generic for: Delsym 12 Hour Cough Relief
• Voriconazole for Injection 200 mg/vial
  Approved: May 30, 2012 - Sandoz, Inc.
  Generic for: Vfend I.V.
• Calcipotriene Cream 0.005%
  Approved: May 30, 2012 - Tolmar, Inc.
  Generic for: Dovonex Cream

April

• Vancomycin Hydrochloride Capsules 125 mg (base) and 250 mg (base)
  Approved: April 9, 2012 - Akorn,Inc.; Strides Arcolab Ltd.; Watson Laboratories, Inc.
  Generic for: Vancocin Capsules
• Fluvastatin Sodium Capsules 20 mg (base) and 40 mg (base)
  Approved - April 11, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Lescol
• Tinidazole Tablets 250 mg and 500 mg
  Approved: April 30, 2012 - Roxane Laboratories, Inc., Novel Labs, Inc.
  Generic for: Tindamax

March

• Fenofibrate Capsules 43 mg and 130 mg
  Approved: March 1, 2012 - Dr Reddy's Laboratories, S.A.
  Generic for: Antara
• Ziprasidone Hydrochloride Tablets 20 mg (base), 40 mg (base), 60 mg (base) and 80 mg (base)
  Approved: March 2, 2012 - Lupin Pharmaceuticals, Inc.; Apotex Corp.; Dr. Reddy's Laboratories Limited
  Generic for: Geodon
• Glycopyrrolate Tablets USP, 1.5 mg
  Approved: March 12, 2012 - Nexgen Pharma, Inc.
  Generic for: Robinul Forte
• Escitalopram Oxalate Tablets 5 mg (base), 10 mg (base) and 20 mg (base)
  Approved: March 14, 2012 - Teva Pharmaceuticals, USA
  Generic for: Lexapro Tablets
• Escitalopram Oxalate Oral Solution 5 mg (base)/5 mL
  Approved: March 14, 2012 - Amneal Pharmaceuticals LLC
  Generic for: Lexapro Oral Solution
• Ibandronate Sodium Tablets 150 mg (base)
  Approved: March 19, 2012 - Apotex Inc.; Mylan Pharmaceuticals Inc.; Orchid Healthcare
  Generic for: Boniva
• Quetiapine Fumarate Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base)
  Approved: March 27, 2012 - Dr. Reddy's Laboratories Limited; Teva Pharmaceuticals, USA; Roxane Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Apotex Corp.; Aurobindo Pharma Limited; Torrent Pharmaceuticals Limited; Lupin Pharmaceuticals Inc.; Sun Pharmaceutical Industries; Accord Healthcare Inc.
  Generic for: Seroquel
• Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg
  Approved: March 30, 2012 - Teva Pharmaceuticals USA
  Generic for: Avalide
• Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg
  Approved: March 30, 2012 - Teva Pharmaceuticals USA
  Generic for: Avapro

February

• Cisatracurium Besylate Injection 2 mg (base)/mL; packaged in 20 mg (base)/10 mL multiple-dose vials
  Approved: February 3, 2012 - Sandoz Inc.
  Generic for: Nimbex Injection
• Cisatracurium Besylate Injection (Preservative Free) 10 mg (base)/mL packaged in 200 mg (base)/20 mL; and 2 mg (base)/mL packaged in 100 mg (base)/5 mL single-dose vials
  Approved: February 3, 2012 - Sandoz Inc.
  Generic for: Nimbex Injection
• Tizanidine Hydrochloride Capsules 2 mg (base), 4 mg (base) and 6 mg (base)
  Approved: February 3, 2012 - Apotex Inc.
  Generic for: Zanaflex Capsules
• Doxycycline Hyclate Delayed-Release Tablets USP, 150 mg (base)
  Approved: February 8, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Doryx Delayed-Release Tablets
Progesterone Capsules 100 mg and 200 mg
Approved: February 29, 2012 - Teva Pharmaceuticals USA
Generic for: Prometrium Capsules

January

• Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution
  Approved: January 25, 2012 - Novel Laboratories, Inc.
  Generic for: Moviprep For Oral Solution

December

• Methylphenidate Hydrochloride Extended-Release Capsules (LA) 20 mg, 30 mg and 40 mg
  Approved: December 1, 2011 - Actavis South Atlantic LLC
  Generic for: Ritalin LA Capsules
• Felbamate Oral Suspension 600 mg/5 mL
  Approved: December 16, 2011 - Amneal Pharmaceuticals
  Generic for: Felbatol Oral Suspension
• Fenofibrate Tablets 48 mg and 145 mg
  Approved: December 23, 2011 - Lupin Limited
  Generic for: Tricor Tablets
• Tramadol Hydrochloride Extended-Release Tablets 100 mg, 200 mg and 300 mg (Once Daily)
  Approved: December 30, 2011 - Sun Pharma Global FZE
  Generic for: Ryzolt Tablets

November

• Tiagabine Hydrochloride Tablets 2 mg and 4 mg
  Approved: November 4, 2011 - Sun Pharmaceutical Industries, Ltd.
  Generic for: Gabitril
• Levocetirizine Dihydrochloride Oral Solution 2.5 mg/5 mL
  Approved: November 7, 2011 - Synthon Pharmaceuticals, Inc.
  Generic for: Xyzal Oral Solution
• Morphine Sulfate Extended-Release Capsules USP 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg
  Approved: November 10, 2011 - Watson Laboratories, Inc.
  Generic for: Kadian
• Eprosartan Mesylate Tablets 400 mg (base) and 600 mg (base)
  Approved: November 16, 2011 - Mylan Pharmaceuticals, Inc.
  Generic for: Teveten
• Imipenem and Cilastatin for Injection USP, (I.V.) 250 mg/250 mg (base) and 500 mg/500 mg (base)
  Approved: November 16, 2011 - Hospira Inc.
  Generic for: Primaxin I.V.
• Lamivudine Tablets 150 mg and 300 mg
  Approved: November 17, 2011 - Aurobindo Pharma USA, Inc.
  Generic for: Epivir Tablets
• Sodium Phenylbutyrate Tablets 500 mg
  Approved: November 18, 2011 - Amplogen Pharmaceuticals, LLC
  Generic for: Buphenyl Tablets
• Atorvastatin Calcium Tablets 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base)
  Approved: November 30, 2011 - Ranbaxy Laboratories Limited
  Generic for: Lipitor

October

• Fluocinolone Acetonide Otic Oil 0.01%
  Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
  Generic for: DermOtic Oil
• Fluocinolone Acetonide Topical Oil 0.01%
  Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
  Generic for: Derma-Smoothe/FS Scalp Oil
• Fluocinolone Acetonide Topical Oil 0.01%
  Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
  Generic for: Derma-Smoothe/FS Body Oil
• Olanzapine Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg
  Approved: October 24, 2011 - Teva Pharmaceuticals USA
  Generic for: Zyprexa
• Olanzapine Tablets 20 mg
  Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd.
  Generic for: Zyprexa
Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg and 20 mg
Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd.; Par Pharmaceutical; Apotex Corp.
Generic for: Zyprexa Zydus
• Olanzapine Intramuscular Injection 10 mg/vial
  Approved: October 24, 2011 - InnoPharma LLC
  Generic for: Zyprexa Injection
• Diethylpropion Hydrochloride Extended-Release Tablets 75 mg
  Approved: October 24, 2011 - Lannett Company, Inc.
  Generic for: Tenuate Dospan
• Memantine Hydrochloride Tablets 5 mg and 10 mg
  Approved: October 25, 2011 - Teva Pharmaceuticals USA
  Generic for: Namenda
• Levonorgestrel & Ethinyl Estradiol Tablets and Ethinyl Estradiol 0.1 mg/0.02 mg; 0.01 mg
  Approved: October 25, 2011 - Watson Laboratories, Inc.
  Generic for: Lo Seasonique
• Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL
  Approved: October 27, 2011 - Pack Pharmaceuticals LLC
  Generic for: Gastrocrom Oral Concentrate
• Epinastine Hydrochloride Ophthalmic Solution 0.05%
  Approved: October 31, 2011 - Pharmaforce Inc.
  Generic for: Elestat

September

• Levetiracetam Extended-Release Tablets 500 mg and 750 mg
  Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA
  Generic for: Keppra XR
• Felbamate Tablets 400 mg and 600 mg
  Approved: September 13, 2011 - Amneal Pharmaceuticals
  Generic for: Felbatol Tablets
• Doxercalciferol Capsules 0.5 mcg
  Approved: September 23, 2011 - Roxane Laboratories, Inc.
  Generic for: Hectorol Capsules

August

• Tranexamic Acid Injection 100 mg/mL; packaged in 1000 mg/10 mL single-dose vials
  Approved: August 10, 2011 - Pharmaforce Inc.
  Generic for: Cyklokapron Injection
• Gatifloxacin Ophthalmic Solution 0.3%
  Approved: August 19, 2011 - Apotex Corp.
  Generic for: Zymar Ophthalmic Solution
• Ketoconazole Foam 2%
  Approved: August 25, 2011 - Perrigo Israel Pharmaceuticals Ltd.
  Generic for: Extina Foam, 2%
• Cevimeline Hydrochloride Capsules 30 mg
  Approved: August 25, 2011 - Apotex Inc.
  Generic for: Evoxac Capsules, 30 mg
• Prilocaine Hydrochloride with Epinephrine Injection USP, 4%/1:200,000; packaged in cartridges for dental use
  Approved: August 30, 2011 - Septodont Inc.
  Generic for: Citanest Forte Dental

July

• Fondaparinux Sodium Injection 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL
  Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited
  Generic for: Arixtra
• Alfuzosin Hydrochloride Extended-Release Tablets 10 mg
  Approved: July 18, 2011 - Apotex Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals; Teva Pharmaceuticals USA; Sun Pharmaceutical Industries Limited
  Generic for: Uroxatral
• Metronidazole Topical Gel 1%
  Approved: July 22, 2011 - Tolmar, Inc.
  Generic for: Metrogel 1%
• Paricalcitol Injection USP, 2 mcg/mL and 5 mcg/mL
  Approved: July 27, 2011 - Sandoz Canada, Inc.
  Generic for: Zemplar Injection
• Phentermine Resin Complex Extended-Release Capsules 15 mg (base) and 30 mg (base)
  Approved: July 28, 2011 - Lannett Company, Inc.
  Generic for: Ionamin

June

• Ethinyl Estradiol and Levonorgestrel Tablets USP 0.02 mg/0.09 mg
  Approved: June 6, 2011 - Watson Laboratories, Inc.
  Generic for: Lybrel
• Clobetasol Propionate Shampoo 0.05%
  Approved: June 7, 2011 - Actavis Mid Atlantic, LLC
  Generic for: Clobex Shampoo
• Clobetasol Propionate Topical Solution USP, (Spray) 0.05%
  Approved: June 16, 2011 - Paddock Laboratories, Inc.
  Generic for: Clobex Spray
• Levofloxacin Injection 25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials
  Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC
  Generic for: Levaquin Injection
• Levofloxacin Tablets 250 mg, 500 mg and 750 mg
  Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd.
  Generic for: Levaquin Tablets
• Levofloxacin Oral Solution 25 mg/mL
  Approved: June 20, 2011 - Hi-Tech Pharmacal Co., Inc.
  Generic for: Levaquin Oral Solution
• Sumatriptan Succinate Injection 6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector
  Approved: June 21, 2011 - Sun Pharma Global FZE
  Generic for: Imitrex Statdose System
• Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets USP, (OTC) 180 mg/240 mg (24-Hour Formulation)
  Approved: June 22, 2011 - Dr. Reddy's Laboratories Limited
  Generic for: Allegra-D 24 Hour Extended-Release Tablets
• Flucytosine Capsules USP, 250 mg and 500 mg
  Approved: June 28, 2011 - Sigmapharm Laboratories, LLC
  Generic for: Ancobon

May

• Fluticasone Propionate Topical Lotion 0.05%
  Approved: May 2, 2011 - Glenmark Generics Inc.
  Generic for: Cutivate Lotion
• Methylergonovine Maleate Tablets 0.2 mg
  Approved: May 2, 2011 - Novel Laboratories, Inc.
  Generic for: Methergine Tablets
• Bromfenac Sodium Ophthalmic Solution/Drops 0.09%
  Approved: May 11, 2011 - Coastal Pharmaceuticals
  Generic for: Xibrom
• Nitrofurantoin Oral Suspension 25 mg/5 mL
  Approved: May 11, 2011 - Amneal Pharmaceuticals
  Generic for: Furadantin Suspension
• Budesonide Capsules 3 mg
  Approved: May 16, 2011 - Mylan Pharmaceuticals Inc.
  Generic for: Entocort EC
• Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg
  Approved: May 20, 2011 - Nostrum Pharmaceuticals, LLC
  Generic for: Carbatrol Capsules
• Eszopiclone Tablets 1 mg, 2 mg and 3 mg
  Approved: May 23, 2011 - Teva Pharmaceuticals USA
  Generic for: Lunesta
• Lamivudine and Zidovudine Tablets 150 mg/300 mg
  Approved: May 25, 2011 - Teva Pharmaceuticals USA Inc.
  Generic for: Combivir
• Ethinyl Estradiol/Levonorgestrel and Ethinyl Estradiol Tablets 0.03 mg/0.15 mg and 0.01 mg
  Approved: May 31, 2011 - Watson Laboratories, Inc.
  Generic for: Seasonique

April

• Exemestane Tablets 25 mg
  Approved: April 1, 2011 - Roxane Laboratories, Inc.
  Generic for: Aromasin Tablets
• Paroxetine Hydrochloride Extended-Release Tablets 37.5 mg (base)
  Approved: April 14, 2011 - Mylan Pharmaceuticals, Inc.
  Generic for: Paxil CR Tablets
• Cyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg and 30 mg
  Approved: April 18, 2011 - Mylan Pharmaceuticals, Inc.
  Generic for: Amrix Extended-Release Capsules
• Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets 5 mg/240 mg (24-Hour Formulation)
  Approved: April 26, 2011 - Dr. Reddy's Laboratories Limited
  Generic for: Clarinex-D 24-Hour Extended-Release Tablets

March

• Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg (28-Day Regimen)
  Approved: March 9, 2011 - Watson Laboratories, Inc.
  Generic for: Ortho Tri-Cyclen Lo Tablets
• Epinastine Hydrochloride Ophthalmic Solution 0.05%
  Approved: March 14, 2011 - Cypress Pharmaceutical, Inc.
  Generic for: Elestat Ophthalmic Solution

February

• Gabapentin Oral Solution 250 mg/5 mL
  Approved: February 18, 2011 - Hi-Tech Pharmacal Co., Inc.
  Generic for: Neurontin Oral Solution
• Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/500 mg and 15 mg/850 mg
  Approved: February 25, 2011 - Mylan Pharmaceuticals, Inc.
  Generic for: Actoplus Met Tablets

January

• Fentanyl Citrate Buccal Tablets, USP 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg
  Approved: January 7, 2011 - Watson Pharmaceuticals, Inc.
  Generic for: Fentora
• Atovaquone and Proguanil Hydrochloride Tablets 250 mg/100 mg
  Approved: January 12, 2011 - Glenmark Generics Inc.
  Generic for: Malarone

December

• Zolpidem Tartrate Extended-Release Tablets 12.5 mg
  Approved: December 3, 2010 - Anchen Pharmaceuticals, Inc.
  Generic for: Ambien CR Tablets, 12.5 mg
• Levofloxacin Ophthalmic Solution 0.5%
  Approved: December 20, 2010 - Apotex Inc.; Nexus Pharmaceuticals, Inc.; Akorn Inc.
  Generic for: Quixin Ophthalmic Solution
• Dutasteride Capsules 0.5 mg
  Approved: December 21, 2010 - Barr Laboratories, Inc.
  Generic for: Avodart Capsules
• Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg (base) and 100 mg (base)
  Approved: December 28, 2010 - Impax Laboratories, Inc.; Mylan Pharmaceuticals, Inc.
  Generic for: Doryx Tablets

November

• Gemcitabine Hydrochloride Injection 2 g base/vial
  Approved: November 15, 2010 - Hospira Inc.
  Generic for: Gemzar
• Zafirlukast Tablets 10 mg and 20 mg
  Approved: November 18, 2010 - Dr Reddys Laboratories Ltd.
  Generic for: Accolate
• Mefenamic Acid Capsules USP, 250 mg
  Approved: November 19, 2010 - Micro Labs Limited
  Generic for: Ponstel Capsules
• Donepezil Hydrochloride Tablets 5 mg and 10 mg
  Approved: November 26, 2010 - Ranbaxy Laboratories Limited
  Generic for: Aricept Tablets
• Levocetirizine Dihydrochloride Tablets 5 mg
  Approved: November 26, 2010 - Synthon Pharmaceuticals, Inc.
  Generic for: Xyzal
• Topotecan Hydrochloride Injection 4 mg base/vial
  Approved: November 29, 2010 - APP Pharmaceuticals, LLC; Fresenius Kabi
  Generic for: Hycamtin

October

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL
  Approved: October 1, 2010 - Tris Pharma, Inc.
  Generic for: Tussionex Pennkinetic Extended-Release Oral Suspension
• Zolpidem Tartrate Extended-Release Tablets USP 6.25 mg
  Approved: October 13, 2010 - Actavis South Atlantic LLC
  Generic for: Ambien CR
• Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg and 30 mg
  Approved: October 15, 2010 - Teva Pharmaceuticals USA
  Generic for: Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets
• Propafenone Hydrochloride Extended-Release Capsules 225 mg, 325 mg and 425 mg
  Approved: October 18, 2010 - Par Pharmaceutical, Inc.
  Generic for: Rythmol SR Capsules

September

• Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg
  Approved September 7, 2010 Watson Laboratories, Inc.
  Generic for: Yasmin Tablets
• Oxymorphone Hydrochloride Tablets 5 mg and 10 mg
  Approved: September 27, 2010 - Roxane Laboratories, Inc.
  Generic for: Opana
• Naphazoline HCl and Pheniramine Maleate Ophthalmic Solution USP 0.027%/0.315% (OTC)
  Approved: September 27, 2010 Altaire Pharmaceuticals, Inc.
  Generic for: Opcon-A

August

• Norethindrone and Ethinyl Estradiol Tablets (Chewable), and Ferrous Fumarate Tablets, (Chewable) 0.4 mg/0.035 mg/75 mg (28-Day Regimen)
  Approved: August 5, 2010 - Barr Laboratories, Inc.
  Generic for: Femcon Fe
• Trospium Chloride Tablets 20 mg
  Approved: August 13, 2010 - Glenmark Generics Ltd.
  Generic for: Sanctura
• Atomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
  Approved: August 30, 2010 - Actavis Elizabeth LLC; Sun Pharma Global; Mylan Pharmaceuticals, Inc.
  Generic for: Strattera

July

• Naratriptan Hydrochloride Tablets 1 mg (base) and 2.5 mg (base)
  Approved: July 7, 2010 - Teva Pharmaceuticals USA Inc.; Sandoz Inc.; Roxane Laboratories, Inc.
  Generic for: Amerge
• Clindamycin Palmitate Hydrochloride for Oral Solution 75 mg (base)/5 mL
  Approved: July 7, 2010 - Paddock Laboratories, Inc.
  Generic for: Cleocin Pediatric Flavored Granules For Oral Solution
• Desloratadine Orally Disintegrating Tablets 2.5 mg and 5 mg
  Approved: July 12, 2010 - Dr.Reddy's Pharmaceutical Company
  Generic for: Clarinex Reditabs

June

• Chlorzoxazone Tablets USP, 375 mg and 750 mg
  Approved: June 1, 2010 - Mikart Inc.
  Generic for: Parafon Forte DSC Caplets
• Adapalene Gel 0.1%
  Approved: June 2, 2010 - Pliva Hrvatska D.O.O.
  Generic for: Differin Gel
• Miconazole Nitrate Vaginal Insert & Miconazole Nitrate Cream 1200 mg/2%
  Approved: June 2, 2010 - Perrigo R&D Company
  Generic for: Monistat 1 Combination Pack
• Oxymorphone Hydrochloride Extended-Release Tablets 5 mg, 10 mg, 20 mg and 40 mg
  Approved: June 14, 2010 - Impax Laboratories, Inc.
  Generic for: Opana ER Tablets
• Aztreonam for Injection USP, 500 mg/vial, 1 g/vial and 2 g/vial
  Approved: June 18, 2010 - APP Pharmaceuticals, LLC
  Generic for: Azactam for Injection
• Articaine Hydrochloride and Epinephrine Injection 4%/1:100,000 (Dental Cartridge)
  Approved: June 18, 2010 - Hospira Inc.
  Generic for: Septocaine and Epinephrine Injection (4%/1:100,000)
• Meropenem for Injection USP, 500 mg/vial and 1 g/vial
  Approved: June 22, 2010 - Hospira, Inc.
  Generic for: Merrem I.V. for Injection
• Anastrozole Tablets 1 mg
  Approved: June 28, 2010 - Accord Healthcare Inc., USA; Natco Pharma Limited; Sandoz Inc.;Stason Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Three Rivers Pharmaceuticals, LLC; Fresenius Kabi Oncology plc;Synthon Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
  Generic for: Arimidex Tablets
• Venlafaxine Hydrochloride Extended-Release Capsules 37.5 mg (base), 75 mg (base) and 150 mg (base)
  Approved: June 28, 2010 - Teva Pharmaceuticals USA
  Generic for: Effexor XR Capsules
• Adapalene Cream 0.1%
  Approved: June 30, 2010 - Nycomed US, Inc.
  Generic for: Differin Cream

May

• Metronidazole Extended-Release Tablets 750 mg
  Approved: May 5, 2010 - Alembic Limited
  Generic for: Flagyl ER Tablets, 750 mg
• Trandolapril and Verapamil Hydrochloride Extended Release Tablets 2 mg/180 mg, 2 mg/240 mg and 4 mg/240 mg
  Approved: May 5 and 26, 2010 - Glenmark Generics Ltd.
  Generic for: Tarka
• Zidovudine Injection 10 mg/mL
  Approved: May 6, 2010 - PharmaForce, Inc.
  Generic for: Retrovir Injection
• Omeprazole and Sodium Bicarbonate Capsules 20 mg/1.1 g and 40 mg/1.1 g
  Approved: May 25, 2010 - Par Pharmaceutical
  Generic for: Zegerid
• Levetiracetam Injection 100 mg/mL; packaged in 500 mg/5 mL Single-Use Vials
  Approved May 26, 2010 - Nexus Pharmaceuticals, Inc.
  Generic for: Keppra Injection
• Famotidine for Suspension 40 mg/5 mL
  Approved: May 27, 2010 - Navinta LLC
  Generic for: Pepcid for Suspension

April

• Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg and 100 mg/25 mg
  Approved: April 6, 2010 Teva Pharmaceuticals USA
  Generic for: Hyzaar Tablets
• Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg
  Approved: April 6, 2010 Roxane Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Ltd.; Teva Pharmaceuticals USA
  Generic for: Hyzaar Tablets
• Losartan Potassium Tablets USP, 25 mg, 50 mg and 100 mg
  Approved: April 6, 2010 Teva Pharmaceuticals USA
  Generic for: Cozaar Tablets
• Memantine Hydrochloride Tablets 5 mg and 10 mg
  Approved: April 14, 2010 Dr. Reddy's Laboratories Limited
  Generic for: Namenda Tablets
• Imipramine Pamoate Capsules 75 mg, 100 mg, 125 mg and 150 mg
  Approved: April 14, 2010 Roxane Laboratories, Inc.; Lupin Limited
  Generic for: Tofranil-PM Capsules
• Amoxicillin & Clavulanate Potassium Extended-Release Tablets 1000 mg/62.5 mg (base)
  Approved: April 21, 2010 Sandoz Inc.
  Generic for: Augmentin XR Tablets
• Voriconazole Tablets 50 mg and 200 mg
  Approved: April 22, 2010 Matrix Laboratories Limited
  Generic for: Vfend Tablets

March

• Temozolomide Capsules 5 mg, 20 mg, 100 mg, 250 mg, 140 mg and 180 mg
  Approved: March 1, 2010 Barr Pharmaceuticals, Inc.
  Generic for: Temodar
• Tamsulosin Hydrochloride Capsules 0.4 mg
  Approved: March 2, 2010 Impax Laboratories, Inc.
  Generic for: Flomax
• Dactinomycin Injection 0.5 mg/vial
  Approved: March 16, 2010 Bedford Laboratories
  Generic for: Cosmegen
• Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets 180 mg / 240 mg
  Approved: March 17, 2010 Company: Dr. Reddy's Laboratories Limited
  Generic for: Allegra-D 24 Hour
• Metaxalone Tablets 800 mg
  Approved: March 31, 2010 Company: Sandoz Inc.
  Generic for: Skelaxin

February

• Desloratadine Tablets 5 mg
  Approved: February 19, 2010 Company: Orchid Healthcare
  Generic for: Clarinex Tablets
• Imiquimod Cream 5%
  Approved: February 25, 2010 Company: Nycomed US, Inc.
  Generic for: Aldara Cream

January

• Ibutilide Fumarate Injection 0.1 mg/mL
  Approved: January 11, 2010 PharmaForce, Inc.; Bioniche Pharma USA LLC.; GeneraMedix Inc.
  Generic for: Corvert

December

• Donepezil Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
  Approved: December 11, 2009 URL Pharma, Inc.
  Generic for: Aricept ODT
• Cromolyn Sodium Oral Concentrate 100 mg/ 5 mL
  Approved: December 18, 2009 Genera Pharmaceuticals, LLC
  Generic for: Gastrocrom
• Cosyntropin Injection 0.25 mg/vial
  Approved: December 23, 2009 GeneraMedix Inc.
  Generic for: Cortrosyn

November

• Ketorolac Tromethamine Ophthalmic Solution 0.5%
  Approved: November 5, 2009 Alcon Inc.; Akorn Inc.; Sun Pharma Global, Inc.
  Generic for: Acular Ophthalmic Solution
• Ketorolac Tromethamine Ophthalmic Solution 0.4%
  Approved: November 5, 2009 Apotex Inc.; Alcon Inc.; Akorn Inc.
  Generic for: Acular LS Ophthalmic Solution
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.005 mg
  Approved: November 6, 2009 Barr Laboratories, Inc.
  Generic for: Femhrt Tablets 1 mg/0.005 mg
• Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg
  Approved: November 10, 2009 Teva Pharmaceuticals USA; Matrix Laboratories Limited
  Generic for: Prevacid Delayed-Release Capsules
• Perindopril Erbumine Tablets 2 mg, 4 mg and 8 mg
  Approved: November 10, 2009 Aurobindo Pharma Limited; Roxane Laboratories, Inc.; IVAX Pharmaceuticals, Inc.
  Generic for: Aceon Tablets
• Tramadol Hydrochloride Extended-Release Tablets 100 mg and 200 mg
  Approved: November 13, 2009 Par Pharmaceutical, Inc.
  Generic for: Ultram ER Tablets, 100 mg and 200 mg
• Nicardipine Hydrochloride Injection 2.5 mg/mL; packaged in 25 mg/10 mL Single-Dise Vials
  Approved: November 17, 2009 Generamedix, Inc.; Pharmaforce, Inc.; Navinta, LLC; Sun Pharma Global, Inc.; Wockhardt Limited
  Generic for: Cardene I.V. Injection
• Nizatidine Oral Solution 15 mg/mL
  Approved: November 18, 2009 Amneal Pharmaceuticals
  Generic for: Axid Oral Solution

October

• Buprenorphine Hydrochloride Sublingual Tablets 2 mg (base) and 8 mg (base)
  Approved: October 8, 2009 Roxane Laboratories, Inc.
  Generic for: Subutex
• Chlorothiazide Sodium for Injection, USP 500 mg (base)/vial
  Approved: October 16, 2009 APP Pharmaceuticals, Inc.
  Generic for: Diuril for Injection

September

• Norethindrone Acetate & Ethinyl Estradiol Tablets USP, & Fe 1 mg/0.02 mg with 75 mg Ferrous Fumarate (24-Day Regimen)
  Approved: September 1, 2009 Watson Laboratotries, Inc.
  Generic for: Loestrin 24 Fe Tablets
• Temazepam Capsules USP, 7.5 mg
  Approved: September 8, 2009 Mutual Pharmaceutical Company, Inc.
  Generic for: Restoril Capsules 7.5 mg
• Nateglinide Tablets 60 mg and 120 mg
  Approved: September 9, 2009 Par Pharmaceutical, Inc.; Dr. Reddy's Laboratories; Teva Pharmaceuticals USA
  Generic for: Starlix Tablets
• Piperacillin and Tazobactam for Injection 36 g (base)/4.5 g (base)/vial, (pharmacy bulk package)
  Approved: September 15, 2009 Orchid Healthcare
  Generic for: Zosyn for Injection (Pharmacy Bulk Package)
• Piperacillin and Tazobactam for Injection 2 g (base)/250 mg (base)/vial, 3 g (base)/375 mg (base)/vial and 4 g (base)/500 mg (base)/vial
  Approved: September 15, 2009 Orchid Healthcare
  Generic for: Zosyn for Injection

August

• Azelastine Hydrochloride Ophthalmic Solution 0.05%
  Approved: August 3, 2009 Apotex Inc.
  Generic for: Optivar Ophthalmic Solution
• Oxaliplatin Injection 5 mg/mL; (preservative-free), packaged in 50 mg/10 mL and 100 mg/20 mL single-use vials
  Approved: August 7, 2009 Hospira Worldwide; Sun Pharma Global; Fresenius Kabi Oncology
  Generic for: Eloxatin Injection
• Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg
  Approved: August 10, 2009 Sandoz, Inc.
  Generic for: Prograf Capsules
• Clindamycin Phosphate and Benzoyl Peroxide Gel 1% (base)/5%
  Approved: August 11, 2009 Dow Pharmaceutical Sciences, Inc.
  Generic for: Benzaclin Topical Gel
• Aspirin and Dipyridamole Extended-Release Capsules 25 mg/200 mg
  Approved: August 14, 2009 Barr Laboratories, Inc.
  Generic for: Aggrenox Extended-Release Capsules
• Clonidine Transdermal System USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day
  Approved: August 18, 2009 Aveva Drug Delivery Systems, Inc.
  Generic for: Catapres-TTS
• Levonorgestrel Tablets (Rx/OTC) 0.75 mg
  Approved: August 28, 2009 Watson Laboratories, Inc.
  Generic for: Plan B Tablets

July

• Bicalutamide Tablets 50 mg
  Approved: July 6, 2009 Teva Pharmaceuticals; Synthon Pharmaceuticals, Inc.; Kudco; Sandoz; Accord Healthcare Inc.; Zydus Pharmaceuticals; Sun Pharmaceutical Industries Ltd; Mylan Pharmaceuticals
  Generic for: Casodex

June

• Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen)
  Approved: June 29, 2009 Barr Laboratories, Inc.
  Generic for: Ortho Tri Cyclen Lo
• Oxcarbazepine Oral Suspension 300 mg/5 mL
  Approved: June 26, 2009 Ranbaxy Laboratories Limited
  Generic for: Trileptal Oral Suspension
• Levonorgestrel Tablets (Rx) 0.75 mg
  Approved: June 24, 2009 Watson Laboratories, Inc.
  Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg
• Melphalan Hydrochloride for Injection 50 mg (base)/vial
  Approved: June 9, 2009 Synerx Pharma, LLC
  Generic for: Alkeran for Injection
• Omeprazole Magnesium Delayed-Release Capsules (OTC) 20 mg (base)
  Approved: June 6, 2009 Dr. Reddy's Laboratories Limited
  Generic for: Prilosec OTC Delayed-Release Capsules
• Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400 mg/10 mL multiple-dose vials
  Approved: June 1, 2009 Sandoz Canada Inc.
  Generic for: Kenalog-40 Injectable Suspension

May

• Triamcinolone Acetonide Injectable Suspension USP 10 mg/mL; packaged in 50 mg/5 mL multiple-dose vials
  Approved: May 27, 2009 Sandoz Canada, Inc.
  Generic for: Kenalog-10 Injectable Suspension

April

• Risperidone Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg
  Approved: April 30, 2009 Kali Laboratories, Inc.
  Generic for: Risperdal-M Tab (Orally Disintegrating Tablet)
• Mivacurium Chloride Injection 2 mg (base)/mL; packaged in 10 mg (base)/5 mL and 20 mg (base)/10 mL single-dose vials
  Approved: April 30, 2009 Ebewe Parenta Pharmaceuticals, Inc.
  Generic for: Mivacron Injection
• Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1% [125 mcg (base)/spray]
  Approved: April 30, 2009 Apotex Inc.
  Generic for: Astelin Nasal Spray
• Lorazepam Oral Concentrate USP 2 mg/mL
  Approved: April 28, 2009 Paddock Laboratories, Inc.
  Generic for: Lorazepam Intensol
• Topiramate Capsules (Sprinkle) 15 mg and 25 mg
  Approved: April 15, 2009 Cobalt Laboratories, Inc.; Barr Laboratories, Inc.
  Generic for: Topamax Sprinkle Capsules

March

• Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg
  Approved: March 31, 2009 Taro Pharmaceuticals USA, Inc.
  Generic for: Tegretol-XR Tablets
• Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.02 mg (28-Day Regimen)
  Approved: March 30, 2009 Barr Laboratories, Inc.
  Generic for: Yaz Tablets
• Topiramate Tablets 25 mg, 50 mg, 100 mg and 200 mg
  Approved: March 27, 2009 Torrent Pharmaceuticals Limited; Ranbaxy Laboratories Limited (not 50 mg); Par Pharmaceutical, Inc.; Cipla Limited; Mylan Pharmaceuticals Inc.; Apotex Inc.; Cobalt Laboratories; Glenmark Generics Limited; Roxane Laboratories, Inc.; Barr Laboratories, Inc. (not 50 mg); Sun Pharmaceutical Industries, Ltd.; Invagen Pharmaceuticals, Inc.; Aurobindo Pharma Limited; Unichem Laboratories Limited (not 200 mg); Zydus Pharmaceuticals USA, Inc.; Teva Pharmaceuticals USA
  Generic for: Topamax Tablets
• Ibuprofen Capsules, 200 mg (Liquid Filled Capsule) (OTC)
  Approved: March 24, 2009 Banner Pharmacaps, Inc.
  Generic for: Advil Liqui-Gels Capsules
• Levalbuterol Inhalation Solution USP, (Concentrate) 0.25% (1.25 mg/0.5mL)
  Approved: March 20, 2009 Dey LP
  Generic for: Xopenex Inhalation Solution (Concentrate)
• Liothyronine Sodium Tablets USP 5 mcg, 25 mcg, and 50 mcg
  Approved: March 20, 2009 Coastal Pharmaceuticals
  Generic for: Cytomel Tablets
• Apraclonidine Ophthalmic Solution USP 0.5% (base)
  Approved: March 12, 2009 Akorn, Inc.
  Generic for: Iopidine Ophthalmic Solution, 0.5%
• Malathion Lotion USP 0.5%
  Approved: March 6, 2009 Synerx Pharma, LLC
  Generic for: Ovide Lotion, 0.5%

February

• Risperidone Orally Disintegrating Tablets 0.5 mg and 2 mg
  Approved: February 24, 2009 Dr. Reddy's Laboratories Limited
  Generic for: Risperdal M-Tab (Orally Disintegrating Tablet)
• Sumatriptan Succinate Tablets 25 mg (base), 50 mg (base) and 100 mg (base)
  Approved: February 9, 2009 Teva Pharmaceuticals USA; Ranbaxy Laboratories Limited (100 mg (base) only)
  Generic for: Imitrex Tablets
• Sumatriptan Succinate Injection (Syringe) 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Pre-Filled Syringes
  Approved: February 6, 2009 Teva Parenteral Medicines
  Generic for: Imitrex Injection, Pre-Filled Syringes
• Sumatriptan Succinate Injection 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Single-Dose Vials
  Approved: February 6, 2009 Sandoz Canada, Inc.; Teva Parenteral Medicines (6 mg (base)/0.5 mL only); Bedford Laboratories (6 mg (base)/0.5 mL only)
  Generic for: Imitrex Injection, Single Dose Vials
• Minocycline Hydrochloride Extended-Release Tablets 45 mg (base), 90 mg (base) and 135 mg (base)
  Approved: February 3, 2009 Impax Laboratories, Inc.
  Generic for: Solodyn Tablets

January

• Galantamine Hydrobromide Oral Solution 4 mg/mL
  Approved: January 30, 2009 Roxane Laboratories, Inc.
  Generic for: Razadyne Oral Solution
• Risperidone Oral Solution 1 mg/mL
  Approved: January 30, 2009 Teva Pharmaceuticals USA
  Generic for: Risperdal Oral Solution
• Divalproex Sodium Extended-Release Tablets 250 mg and 500 mg
  Approved: January 29, 2009 Mylan Pharmaceuticals, Inc.
  Generic for: Depakote ER Tablets, 250 mg and 500 mg
• Divalproex Sodium Delayed Release Capsules (Sprinkle) 125 mg (valproic acid equivalent)
  Approved: January 23, 2009 Dr. Reddy's Laboratories, Inc.
  Generic for: Depakote Sprinkle Capsules, 125 mg
• Levetiracetam Oral Solution 100 mg/mL
  Approved: January 15, 2009 Roxane Laboratories, Inc.; Tolmar Inc.; Aurobindo Pharma Ltd.; Actavis Mid Atlantic LLC
  Generic for: Keppra Oral Solution
• Alprazolam Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg
  Approved: January 9, 2009 Kali Laboratories, Inc.
  Generic for: Niravam Orally Disintegrating Tablets

December

• Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg
  Approved: December 29, 2008 Hetero Drugs Limited; Aurobindo Pharma Limited; Matrix Laboratories Limited
  Generic for: Zerit Capsules
• Stavudine for Oral Solution USP, 1 mg/mL; (200 mL upon reconstitution)
  Approved: December 29, 2008 Aurobindo Pharma USA, Inc.
  Generic for: Zerit for Oral Solution
• Letrozole Tablets USP, 2.5 mg
  Approved: December 24, 2008 Mylan Pharmaceuticals, Inc.
  Generic for: Femara Tablets
• Ibuprofen and Diphenhydramine Citrate Tablets (OTC), 200 mg/38 mg
  Approved: December 22, 2008 Perrigo R&D Company
  Generic for: Advil PM Tablets
• Gemcitabine for Injection USP, 200 mg/single-use vial and 1 gram/single-use vial
  Approved: December 18, 2008 Teva Parenteral Medicines, Inc.
  Generic for: Gemzar for Injection
• Acetazolamide Extended Release Capsules 500 mg
  Approved: December 10, 2008 Zydus Pharmaceuticals USA Inc.
  Generic for: Diamox Capsules
• Clobetasol Propionate Lotion 0.05%
  Approved: December 4, 2008 Actavis Mid Atlantic LLC
  Generic for: Clobex Topical Lotion

November

• Rocuronium Bromide Injection 10 mg/mL packaged in 5 mL and 10 mL Multiple-Dose Vials
  Approved: November 26, 2008 Hospira Inc.; Teva Parenteral Medicines, Inc.; Generamedix, Inc.
  Generic for: Zemuron Injection
• Methylergonovine Maleate Injection USP 0.2 mg/mL
  Approved: November 24, 2008 Pharmaforce, Inc.
  Generic for: Methergine
• Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL; packaged in Unit-Dose Vials
  Approved: November 18, 2008 IVAX Pharmaceuticals
  Generic for: Pulmicort Respules Inhalation Suspension
• Calcitonin-Salmon Nasal Spray 200 IU/Spray
  Approved: November 17, 2008 Apotex, Inc.
  Generic for: Miacalcin Nasal Spray
• Levetiracetam Tablets 250 mg, 500 mg and 750 mg
  Approved: November 3, 2008 Mylan Pharmaceuticals, Inc.
  Generic for: Keppra Tablets

October

• Dorzolamide HCl and Timolol Maleate Ophthalmic Solution 2% (base)/0.5% (base)
  Approved: October 28, 2008 Hi-Tech Pharmacal Co., Inc.; Apotex Inc.
  Generic for: Cosopt Ophthalmic Solution
• Dorzolamide Hydrochloride Ophthalmic Solution 0.2% (base)
  Approved: October 28, 2008 Apotex Inc.; Hi-Tech Pharmacal Company, Inc.
  Generic for: Trusopt Ophthalmic Solution

September

• Galantamine Hydrobromide Extended-Release Capsules 8 mg, 16 mg and 24 mg
  Approved: September 15, 2008 Barr Laboratories, Inc.
  Generic for: Razadyne ER
• Ketamine Hydrochloride Injection USP, 200 mg (base)/20 mL multiple-dose vials
  Approved: September 30, 2008 Bioniche Pharma USA
  Generic for: Ketalar Injection

August

• Galantamine Tablets USP 4 mg, 8 mg and 12 mg
  Approved: August 28, 2008 Barr Laboratories, Inc.; Alphapharm Pty Ltd.
  Generic for: Razadyne Tablets

July

• Indomethacin for Injection USP 1 mg/vial
  Approved: July 16, 2008 Bedford Laboratories
  Generic for: Indocin IV, 1 mg/Vial
• Doxycycline for Oral Suspension USP, 25 mg/5 mL
  Approved: July 16, 2008 IVAX Pharmaceuticals, Inc.
  Generic for: Vibramycin for Oral Suspension, 25 mg/5 mL
• Nisoldipine Extended Release Tablets 20 mg, 30 mg and 40 mg
  Approved: July 25, 2008 Mylan Pharmaceuticals, Inc.
  Generic for: Sular Extended-Release Tablets
• Mycophenolate Mofetil Capsules 250 mg
  Approved: July 29, 2008 Roxane Laboratories, Inc.
  Generic for: Cellcept Capsules, 250 mg
• Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg (Valproic Acid Activity)
  Approved: July 29, 2008 Dr. Reddy's Laboratories Limited; Sun Pharmaceutical Industries, Ltd.; Genpharm ULC; Upsher-Smith Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA; Lupin Limited
  Generic for: Depakote Delayed-Release Tablets
• Mycophenolate Mofetil Tablets 500 mg
  Approved: July 29, 2008 Roxane Laboratories, Inc.
  Generic for: Cellcept Tablets, 500 mg
• Eplerenone Tablets 25 mg and 50 mg
  Approved: July 30, 2008 Apotex, Inc.
  Generic for: Inspra Tablets, 25 mg and 50 mg

June

• Zaleplon Capsules 5 mg and 10 mg
  Approved: June 6, 2008 Sandoz Inc.; Genpharm ULC; Unichem Laboratories Limited; Aurobindo Pharma Limited; Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA; Roxane Laboratories, Inc.
  Generic for: Sonata Capsules
• Prednisolone Sodium Phosphate Oral Solution 20 mg (base)/5 mL (new strength)
  Approved: June 9, 2008 Pharmaceutical Associates, Inc.
  Generic for: Orapred Oral Solution
• Ciclopirox Gel 0.77%
  Approved: June 10, 2008 Nycomed US, Inc.
  Generic for: Loprox Gel
• Torsemide Injection 10 mg/mL; 2 mL and 5 mL vials
  Approved: June 10, 2008 Bedford Laboratories
  Generic for: Demadex Injection, 10 mg/mL
• Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mg
  Approved: June 27, 2008 Par Pharmaceutical, Inc.
  Generic for: Marinol Capsules, 2.5 mg, 5 mg, 10 mg
• Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
  Approved: June 30, 2008 Teva Pharmaceuticals USA
  Generic for: Risperdal Tablets

May

• Ropinirole Hydrochloride Tablets 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
  Approved: May 5, 2008 Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.
  Generic for: Requip Tablets
• Calcipotriene Topical Solution 0.005% (Scalp Solution)
  Approved: May 6, 2008 Nycomed US, Inc.
  Generic for: Dovonex Scalp Solution, 0.005%
• Acarbose Tablets 25 mg, 50 mg, and 100 mg
  Approved: May 7, 2008 Roxane Laboratories, Inc.; Cobalt Laboratories
  Generic for: Precose Tablets
• Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg; (28-day regimen)
  Approved: May 9, 2008 Barr Laboratories, Inc.
  Generic for: Yasmin Tablets
• Fluoxetine Capsules USP 10 mg and 20 mg
  Approved: May 20, 2008 Teva Pharmaceuticals USA
  Generic for: Sarafem Pulvules
• Cetirizine Hydrochloride Syrup 1 mg/mL (Rx only)
  Approved: May 27, 2008 Teva Pharmaceuticals USA
  Generic for: Zyrtec Syrup (Rx only)
• Omeprazole Delayed-Release Capsules USP, 40 mg
  Approved: May 30, 2008 Andrx Pharmaceuticals, LLC
  Generic for: Prilosec Delayed-Release Capsules 40 mg

April

• Cetirizine Hydrochloride Oral Solution 1 mg/mL (OTC)
  Approved: April 9, 2008 Perrigo R&D Company
  Generic for: Children's Zyrtec Allergy And Hives-Relief
• Levalbuterol Hydrochloride Inhalation Solution 0.31 mg (base), 0.63 mg (base), and 1.25 mg (base); packaged in 3 mL Unit-Dose Vials
  Approved: April 9, 2008 Breath Limited
  Generic for: Xopenex Inhalation Solution
• Fluorouracil Cream USP, 5%
  Approved: April 11, 2008 Spear Pharmaceuticals, Inc.
  Generic for: Efudex Topical Cream, 5%
• Estradiol And Norethindrone Acetate Tablets 1 mg/0.5 mg
  Approved: April 17, 2008 Breckenridge Pharmaceutical, Inc.
  Generic for: Activella Tablets
• Ribavirin Tablets 500 mg (New Strength)
  Approved: April 18, 2008 Zydus Pharmaceuticals USA, Inc.
  Generic for: Copegus Tablets
• Epoprostenol Sodium for Injection 0.5 Mg (base)/vial and 1.5 mg (base)/vial
  Approved: April 23, 2008 Teva Parenteral Medicines, Inc.
  Generic for: Flolan for Injection
• Donepezil Hydrochloride Tablets 5 mg and 10 mg
  Approved: April 28, 2008 Teva Pharmaceuticals USA
  Generic for: Aricept Tablets

March

• Prednisolone Sodium Phosphate Oral Solution, 10 mg (base)/5 mL
  Approved: March 7, 2008 Pharmaceutical Associates, Inc.
  Generic for: Orapred Oral Solution
• Clobetasol Propionate Foam 0.05%
  Approved: March 10, 2008 Perrigo Israel Pharmaceuticals, Ltd.
  Generic for: Olux Foam
• Amifostine for Injection USP, 500 mg/vial
  Approved: March 14, 2008 Sun Pharmaceutical Indistries, Ltd.
  Generic for: Ethyol for Injection
• Ciprofloxacin and Dextrose 5% Injection USP, 2 mg/mL; packaged in 200 mg/100 mL and 400 mg/200 mL Flexible Plastic Containers
  Approved: March 18, 2008 Baxter Healthcare Corporation; ACS Dobfar Info S.A.; Claris Lifesciences Limited; Hospira, Inc.
  Generic for: Cipro I.V. in Dextrose 5% Injection
• Metronidazole Injection USP 5 mg/mL (100 mL containers)
  Approved: March 31, 2008 Claris Lifescience Ltd.
  Generic for: Flagyl I.V. RTU Injection, 500 mg/100 mL

February

• Cefuroxime Axetil for Oral Solution USP 125 mg/5 mL and 250 mg/5 mL
  Approved: February 5, 2008 Ranbaxy Pharmaceuticals, Inc.
  Generic for: Ceftin for Oral Suspension
• Famotidine, Calcium Carbonate, Magnesium Hydroxide 10 mg/800 mg/165 mg Chewable Tablets
  Approved: February 6, 2008 Perrigo R&D Company
  Generic for: Pepcid Complete
• Alendronate Sodium Tablets USP, 5 mg (base), 10 mg (base), and 40 mg (base) for Once-Daily Dosing; and 35 mg (base) and 70 mg (base) for Once-Weekly Dosing
  Approved: February 6, 2008 Teva Pharmaceuticals USA; Barr Laboratories, Inc. (70 mg Once-Weekly only)
  Generic for: Fosamax Tablets
• Pramipexole Dihydrochloride Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg
  Approved: February 19, 2008 Barr Laboratories, Inc.
  Generic for: Mirapex Tablets
• Irinotecan Hydrochloride Injection 20 mg/mL; packaged in 40 mg/2 mL and 100 mg/5 mL single-use vials
  Approved: February 20, 2008 Watson Laboratories, Inc.
  Generic for: Camptosar Injection
• Cetirizine HCl and Pseudoephedrine HCl Extended-Release Tablets 5 mg/120 mg
  Approved: February 25, 2008 Teva Pharmaceuticals USA
  Generic for: Zyrtec-D Extended-Release Tablets
• Calcium Acetate Capsules 667 mg (equivalent to 169 mg calcium)
  Approved: February 26, 2008 Roxane Laboratories, Inc.
  Generic for: Phoslo Gelcaps
• Granisetron Hydrochloride Oral Solution 2 mg (base)/10 mL
  Approved: February 28, 2008 Cypress Pharmaceutical, Inc.
  Generic for: Kytril Oral Solution, 2 mg/10 mL

January

• Cetirizine Hydrochloride Chewable Tablets 5 mg and 10 mg
  Approved: January 11, 2008 Caraco Pharmaceutical Laboratories, Ltd.
  Generic for: Zyrtec Allergy Tablets and Zyrtec Hives Relief
• Technetium Tc-99m Mebrofenin Kit (Injection) 45 mg/vial
  Approved: January 29, 2008 CIS-US, Inc.
  Generic for: Choletec Kit For Injection
• Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL
  Approved: January 29, 2008 Outlook Pharmaceuticals, Inc.
  Generic for: Dexedrine Oral Solution (Elixir)
• Calcium Acetate Tablets USP, 667 mg
  Approved: January 30, 2008 Roxane Laboratories, Inc.
  Generic for: Phoslo Tablets, 667 mg

December

• Fomepizole Injection 1 g/mL
  Approved: December 14, 2007 Pharmaforce, Inc.
  Generic for: Antizol Injection
• Extended Phenytoin Sodium Capsules USP 30 mg
  Approved: December 18, 2007 Wockhardt Limited
  Generic for: Dilantin (Extended Phenytoin Sodium Capsules)
• Cetirizine Hydrochloride Tablets (OTC) 5 mg and 10 mg
  Approved: December 27, 2007 Mylan Pharmaceuticals, Inc.; Caraco Pharmaceutical Laboratories, Ltd.; Par Pharmaceutical, Inc.; Ranbaxy Laboratories Limited; Sandoz Inc.
  Generic for: Zyrtec Allergy Tablets/Zyrtec Hives Relief Tablets
• Diclofenac Sodium Ophthalmic Solution 0.1%
  Approved: December 28, 2007 Bausch & Lomb Inc.; Nexus Pharmaceuticals, Inc.
  Generic for: Voltaren Ophthalmic Solution
• Balsalazide Disodium Capsules 750 mg
  Approved: December 28, 2007 Roxane Laboratories, Inc.
  Generic for: Colazal Capsules
• Granisetron Hydrochloride Injection 0.1 mg (base)/1 mL; packaged in 0.1 mg (base)/ 1 mL Single-Use Vials
  Approved: December 31, 2007 App Pharmaceuticals, LLC; Watson Laboratories, Inc.
  Generic for: Kytril Injection
• Granisetron Hydrochloride Injection (Preservative-Free) 1 mg (base)/mL; packaged in 1 mg (base)/1 mL Single-Dose Vials
  Approved: December 31, 2007 Teva Parenteral Medicines, Inc.
  Generic for: Kytril Injection
• Granisetron Hydrochloride Injection 1 mg (base)/mL; packaged in 4 mg (base)/4 mL Multiple-Dose Vials
  Approved: December 31, 2007 Baxter Healthcare Corporation
  Generic for: Kytril Injection
• Granisetron Hydrochloride Tablets 1 mg (base)
  Approved: December 31, 2007 Barr Laboratories, Inc.; Teva Pharmaceuticals USA; Corepharma LLC; Roxane Laboratories, Inc.
  Generic for: Kytril Tablets

November

• Oxycodone Hydrochloride and Ibuprofen Tablets 5 mg/400 mg
  Approved: November 26, 2007 Watson Laboratories, Inc.
  Generic for: Combunox Tablets

October

• Nifedipine Extended-Release Tablets USP, 90 mg
  Approved: October 3, 2007 Osmotica Pharmaceutical Corp.
  Generic for: Procardia XL Tablets
• Risedronate Sodium Tablets 5 mg, 30 mg, and 35 mg
  Approved: October 5, 2007 Teva Pharmaceuticals USA
  Generic for: Actonel Tablets
• Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg
  Approved: October 9, 2007 Roxane Laboratories, Inc.; Glenmark Pharmaceuticals, Ltd; Sun Pharmaceutical Industries Ltd.
  Generic for: Trileptal Tablets
• Hydrocodone Bitartrate and Ibuprofen Tablets 2.5 mg/200 mg (New Strength)
  Approved: October 19, 2007 Interpharm Inc.
  Generic for: Vicoprofen Tablets
• Rivastigmine Tartrate Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base), and 6 mg (base)
  Approved: October 22, 2007 Sun Pharmaceutical Industries, Ltd.
  Generic for: Exelon Capsules
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg (21-Day and 28-Day)
  Approved: October 26, 2007 Barr Laboratories, Inc.
  Generic for: Estrostep-21 and Estrostep Fe Tablets

September

• Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg
  Approved: September 5, 2007 - Dr. Reddy's Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Lupin Limited; Caraco Pharmaceutical Laboratories Ltd.; Ranbaxy Laboratories Limited; Glenmark Pharmaceuticals Limited; Teva Pharmaceuticals USA
  Generic for: Coreg Tablets
• Ciclopirox Topical Solution (Nail Lacquer) 8%
  Approved: September 18, 2007 - G & W Laboratories, Inc.; Taro Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis Mid Atlantic LLC; Hi-Tech Pharmacal Co., Inc.; Perrigo Company; Apotex Inc.; Tolmar Inc.; Synerx Pharma, LLC; Teva Pharmaceuticals USA
  Generic for: Penlac Nail Lacquer
• Hydrocodone Polistirex and Chlorpheniramine Polistirex 5 mg/4 mg and 10 mg/8 mg
  Approved: September 24, 2007 - Tyco Healthcare Mallinckrodt
  Generic for: Tussinonex Pennkinetic ER Suspension
• Albuterol Sulfate Inhalation Solution 0.021% (base) and 0.042% (base)
  Approved: September 25, 2007 - Watson Laboratories, Inc.
  Generic for: Accuneb Inhalation Solution
• Ofloxacin Otic Solution USP, 0.3%
  Approved: September 28, 2007 - Apotex Inc.
  Generic for: Floxin Otic Solution

August

• Pantoprazole Sodium Delayed-Release Tablets 20 mg (Base) and 40 mg (Base)
  Approved: August 2, 2007 - Teva Pharmaceuticals USA
  Generic for: Protonix Delayed-Release Tablets
• Fosphenytoin Sodium Injection USP, 75 mg/mL
  Approved: August 6, 2007 - Teva Parenteral Medicines, Inc.
  Generic for: Cerebyx Injection
• Pentostatin For Injection 10 mg/vial
  Approved: August 7, 2007 - Bedford Laboratories
  Generic for: Nipent Injection
• Verapamil Hydrochloride Extended-Release Capsules (PM) 100 mg, 200 mg, and 300 mg
  Approved: August 9, 2007 - Mylan Pharmaceuticals, Inc.
  Generic for: Verelan PM Extended-Release Capsules
• Cefotetan For Injection USP, 1 gram/vial, 2 grams/vial and 10 grams/vial
  Approved: August 9, 2007 - Abraxis Pharmaceutical Products
  Generic for: Cefotan For Injection
• Famciclovir Tablets 125 mg, 250 mg and 500 mg
  Approved: August 24, 2007 - Teva Pharmaceuticals USA
  Generic for: Famvir Tablets

July

• Dantrolene Sodium for Injection 20 mg/vial
  Approved: July 24, 2007 - US Worldmeds, LLC
  Generic for: Dantrium Intravenous 20 mg/vial
• Escitalopram Oxalate Capsules 5 mg (base), 10 mg (base) and 20 mg (base)
  Approved: July 31, 2007 - Alphapharm Pty. Ltd.
  Generic for: Lexapro Tablets

June

• Benzonatate Capsules USP, 100 mg and 200 mg
  Approved: June 8, 2007 - Zydus Pharmaceuticals USA, Inc.
  Generic for: Tessalon Capsules (Perles)
• Cefepime for Injection USP, 500 mg/vial, 1 gram/vial and 2 grams/vial
  Approved: June 18, 2007 - Orchid Healthcare
  Generic for: Maxipime For Injection
• Tretinoin Capsules 10 mg
  Approved: June 21, 2007 - Barr Laboratories, Inc.
  Generic for: Vesanoid Capsules, 10 mg
• Paroxetine Hydrochloride Extended-Release Tablets, 12.5 mg (base) and 25 mg (base)
  Approved: June 29, 2007 - Mylan Pharmaceuticals, Inc.
  Generic for: Paxil CR Extended-Release Tablets

May

• Metoprolol Succinate Extended-Release Tablets USP, 50 mg
  Approved: May 18, 2007 - Sandoz Inc.
  Generic for: Toprol-XL Extended-Release Tablets 50 mg
• Metoprolol Succinate Extended-Release Tablets USP, 100 mg and 200 mg
  Approved: May 18, 2007 - KV Pharmaceutical Company
  Generic for: Toprol-XL Extended-Release Tablets
• Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg, and 10 mg (base)/20 mg
  Approved: May 18, 2007 - Teva Pharmaceuticals, USA
  Generic for: Lotrel Capsules
• Betamethasone Dipropionate Lotion USP, (Augmented) 0.05%
  Approved: May 21, 2007 - Taro Pharmaceuticals USA, Inc.; Altana Inc.
  Generic for: Diprolene Lotion (Augmented)

April

• Cefixime for Oral Suspension USP, 200 mg/5 mL
  Approved: April 10, 2007 - Lupin Limited
  Generic for: Cefixime for Oral Suspension
• Nimodipine Capsules, 30 mg
  Approved: April 17, 2007 - Sun Pharmaceutical Industries, Inc.
  Generic for: Nimotop Capsules
• Zolpidem Tartrate Tablets 5 mg and 10 mg
  Approved: April 23, 2007 - Synthon Pharmaceuticals, Inc.; Apotex Inc.; Ranbaxy Laboratories Limited; Dr. Reddy's Laboratories Ltd.; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Par Pharmaceutical, Inc.; Carlabad Technology, Inc.; Genpharm Inc.; Mutual Pharmaceutical Company, Inc.; Caraco Pharmaceutical Laboratotries, Ltd; Lek Pharmaceuticals, D.D.; Teva Pharmaceuticals USA
  Generic for: Ambien Tablets
• Pravastatin Sodium Tablets 10 mg, 20 mg, 40 mg, and 80 mg
  Approved: April 23, 2007 - Ranbaxy Inc.
  Generic for: Pravachol Tablets

March

• Moexipril HCl and Hydrochlorothiazide Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg
  Approved: March 7, 2007 - Teva Pharmaceuticals, USA
  Generic for: Uniretic Tablets
• Didanosine for Oral Solution (Pediatric Powder), 10 mg/mL; 2 gram and 4 gram Containers
  Approved: March 8, 2007 - Aurobindo Pharma Limited
  Generic for: Videx for Oral Solution
• Prednicarbate Ointment 0.1%
  Approved: March 9, 2007 - Altana Inc.
  Generic for: Dermatop Ointment
• Ciprofloxacin Extended-Release Tablets 500 mg and 1000 mg
  Approved: March 22, 2007 - Mylan Pharmaceuticals Inc.
  Generic for: Cipro XL Tablets
• Nadolol and Bendroflumethiazide Tablets USP, 40 mg/5 mg and 80 mg/5 mg
  Approved: March 30, 2007 - Impax Laboratories, Inc.
  Generic for: Corzide Tablets

February

• Sertraline Hydrochloride Tablets 25 mg (base) 50 mg (base), 100 mg (base), 150 mg (base) and 200 mg (base)
  Approved: February 6, 2007 - Ranbaxy Laboratories Limited
  Generic for: Zoloft Tablets
• Ranitidine Oral Solution USP 15 mg/mL
  Approved: February 21, 2007 - Actavis Mid Atlantic LLC
  Generic for: Zantac Syrup
• Rabeprazole Sodium Delayed-Release Tablets 20 mg
  Approved: February 21, 2007 - Teva Pharmaceuticals USA
  Generic for: Aciphex Delayed-Release Tablets
• Citalopram Hydrobromide Capsules 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: February 28, 2007 - Alphapharm Pty. Ltd.
  Generic for: Celexa Tablets

January

• Hydrochlorothiazide Tablets 12.5 mg
  Approved: January 23, 2007 - Mylan Pharmaceuticals, Inc.
  Generic for: Hydrochlorothiazide Tablets
• Fentanyl Transdermal System 12 mcg/hour
  Approved: January 23, 2007 - Mylan Technologies, Inc.
  Generic for: Duragesic-12 Transdermal System
• Propranolol HCl Extended-Release Capsules 60 mg, 80 mg, 120 mg, and 160 mg
  Approved: January 26, 2007 - Par Pharmaceuticals, Inc.
  Generic for: Inderal LA Capsules
• Dexmethylphenidate Hydrochloride Tablets 2.5 mg, 5 mg, and 10 mg
  Approved: January 29, 2007 - Teva Pharmaceuticals USA
  Generic for: Focalin Tablets
• Valacyclovir Hydrochloride Tablets 500 mg (base) and 1 gram (base)
  Approved: January 31, 2007 - Ranbaxy Inc.
  Generic for: Valtrex Caplets

December

First Time Generic Approvals

• Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg
  Approved: December 28, 2006 Boca Pharmacal, Inc.
  Generic for: Pamine Tablets & Pamine Forte Tablets
• Ondansetron Orally Disintegrating Tablets USP, 4 mg, 8 mg, 16 mg and 24 mg
  Approved: December 26, 2006 Kali Laboratories, Inc.
  Generic for: Zofran ODT
• Ondansetron Hydrochloride Tablets 4 mg (base), 8 mg (base), 16 mg (base) and 24 mg (base)
  Approved: December 26, 2006 Dr. Reddy’s Laboratories Limited
  Generic for: Zofran Tablets
• Ondansetron Oral Solution USP, 4 mg/5 mL
  Approved: December 26, 2006 Roxane Laboratories, Inc.
  Generic for: Zofran Oral Solution
• Albuterol Sulfate & Ipratropium Bromide Inhalation Solution 3 mg (0.083%) and 0.5 mg (0.017%); 3 mL vials
  Approved: December 21, 2006 Sandoz Inc.
  Generic for: Duoneb Inhalation Solution
• Bupropion Hydrochloride Extended-Release Tablets USP, 150 mg and 300 mg (once-a-day)
  Approved: December 14, 2006 Anchen Pharmaceuticals, Inc.
  Generic for: Wellbutrin XL Extended Release Tablets
• Trandolapril Tablets 1 mg, 2 mg, and 4 mg
  Approved: December 12, 2006 Teva Pharmaceuticals USA
  Generic for: Mavik Tablets
• Paroxetine Hydrochloride Oral Suspension, 10 mg/5 mL
  Approved: December 4, 2006 Apotex Inc.
  Generic for: Paxil Oral Suspension
• Oxandrolone Tablets USP, 2.5 mg and 10 mg
  Approved: December 1, 2006 Upsher-Smith Laboratories, Inc. (2.5 mg); Sandoz Inc. (2.5 mg and 10 mg)
  Generic for: Oxandrin Tablets

Other Generic Approvals

• Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL
  Approved: December 28, 2006 Aurobindo Pharma Limited
• Albuterol Sulfate Syrup 2 mg (base)/5 mL
  Approved: December 27, 2006 Vintage Pharmaceuticals, LLC
• Bisoprolol Fumarate Tablets USP, 5 mg and 10 mg
  Approved: December 27, 2006 Aurobindo Pharma Limited
• Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg
  Approved: December 27, 2006 OHM Laboratories, Inc.
• Ondansetron Injection USP, (Preservative-Free) 2 mg/mL; 2 mL vials
  Approved: December 26, 2006 Abraxix Pharmaceutical Products; Apotex Inc.; Baxter Healthcare Corporation; Bedford Laboratories; Hikma Farmaceutica (Portugal), S.A.; Hospira Inc.; Mayne Pharma (USA), Inc.; Pharmaforce, Inc.; Sun Pharmaceutical Industries, Ltd.; Wockhardt Limited
• Ondansetron Injection USP, 2 mg/mL; 20 mL vials
  Approved: December 26, 2006 Abraxis Pharmaceutical Products; Apotex Inc.; Baxter Healthcare Corporation; Bedford Laboratories; Hikma Farmaceutica (Portugal), S.A.; Hospira Inc.; Mayne Pharma (USA), Inc.; Pharmaforce, Inc.; Pliva Hrvatska d.o.o.; Sun Pharmaceutical Industries, Ltd.; Wockhardt Limited
• Finasteride Tablets USP, 5 mg
  Approved: December 22, 2006 Gedeon Richter Ltd.; Mylan Pharmaceuticals, Inc. (approved 12/18/06); Teva Pharmaceuticals, USA (approved 12/15/06)
• Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg
  Approved: December 20, 2006 Aurobindo Pharma Limited; Cobalt Pharmaceuticals, Inc.; Dr. Reddy’s Laboratories Limited (excludes 5 mg); Perrigo R & D Company; Sandoz Inc.; Zydus Pharmaceuticals USA, Inc.
• Meloxicam Tablets 7.5 mg and 15 mg
  Approved: December 20, 2006 Carlsbad Technology Inc. (approved 12/7/06); Ranbaxy Laboratories Ltd. (approved 12/14/06) ; Unichem Laboratories Limited
• Fluconazole for Oral Suspension 10 mg/mL and 40 mg/mL
  Approved: December 18, 2006 Taro Pharmaceutical Industries Ltd.
• Ciclopirox Topical Suspension USP, 0.77%
  Approved: December 15, 2006 Perrigo New York, Inc.
• Bupropion HCl Extended-Release Tablets USP, 300 mg
  Approved: December 15, 2006 Impax Laboratories, Inc.
• Idarubicin Hydrochloride Injection 1 mg/mL; 5 mL, 10 mL, and 20 mL vials
  Approved: December 14, 2006 Bedford Laboratories
• Nifedipine Extended-Release Tablets USP, 30 mg and 60 mg
  Approved: December 13, 2006 Abrika Pharmaceuticals, Inc.
• Ciprofloxacin Ophthalmic Solution USP, 0.3%
  Approved: December 13, 2006 Nexus Pharmaceuticals, Inc.
• Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg
  Approved: December 13, 2006 IVAX Pharmaceuticals Inc.
• Cefprozil Tablets USP, 250 mg and 500 mg
  Approved: December 13, 2006 Ranbaxy Laboratories Limited
• Triamcinolone Acetonide Lotion USP, 0.1%
  Approved: December 13, 2006 Vintage Pharmaceuticals, LLC
• Amantadine Hydrochloride Oral Solution USP, 50 mg/5 mL
  Approved: December 12, 2006 Vintage Pharmaceuticals
• Testosterone Cypionate Injection USP, 200 mg/mL
  Approved: December 11, 2006 Synerx Pharma, LLC
• Extended Phenytoin Sodium Capsules USP, 100 mg
  Approved: December 11, 2006 Sun Pharmaceutical Industries Ltd
• Promethazine, Phenylephrine, Codeine Oral Solution 6.25 mg/5 mg/10 mg per 5 mL
  Approved: December 7, 2006 Vintage Pharmaceuticals, LLC
• Promethazine HCl and Phenylephrine HCl Oral Solution 6.25 mg/5 mg per 5 mL
  Approved: December 7, 2006 Vintage Pharmaceuticals, LLC

November

First Time Generic Approvals

• Cefazolin for Injection USP, (Pharmacy Bulk Package) 100 grams (base)/vial and 300 grams (base)/vial
  Approved: November 29, 2006 Samson Medical Technologies, L.L.C.
  Generic for: Kefzol for Injection
• Ondansetron Injection USP, 2 mg/mL; 2 mL single-dose vials and 20 mL multiple-dose vials
  Approved: November 22, 2006 Teva Pharmaceuticals USA
  Generic for: Zofran Injection
• Ondansetron and Dextrose Injection, 0.64 mg/mL, 50 mL Flexible Plastic Containers
  Approved: November 22, 2006 Sicor Pharmaceuticals, Inc.
  Generic for: Zofran Injection Premixed In Dextrose
• Pravastatin Sodium Tablets 10 mg, 20 mg, 30 mg, and 40 mg
  Approved: November 21, 2006 Pliva Hrvatska d.o.o.
  Generic for: Pravachol Tablets
• Sulfacetamide Sodium Topical Suspension USP, 10%
  Approved: November 17, 2006 Altana Inc.
  Generic for: Klaron Lotion
• Oxybutynin Chloride Extended-Release Tablets 5 mg and 10 mg
  Approved: November 9, 2006 Mylan Pharmaceuticals Inc.
  Generic for: Ditropan XL Extended-Release Tablets
• Oxybutynin Chloride Extended-Release Tablets 15 mg
  Approved: November 9, 2006 Impax Laboratories, Inc.
  Generic for: Ditropan XL Extended-Release Tablets

Other Generic Approvals

• Moexipril Hydrochloride Tablets, 7.5 mg and 15 mg
  Approved: November 30, 2006 Paddock Laboratories, Inc.
• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base) and 40 mg (base)
  Approved: November 30, 2006 Interpharm Inc.
• Paclitaxel Injection USP, 6 mg/mL; 5 mL, 16.7 mL, and 50 mL vials
  Approved: November 27, 2006 Dabur Oncology plc
• Doxycycline Tablets, 50 mg, 75 mg, and 100 mg
  Approved: November 27, 2006 Sandoz Inc.
• Ampicillin and Sulbactam for Injection USP, 10 grams (base)/5 grams (base) 15 g Pharmacy Bulk Package
  Approved: November 27, 2006 Instituto Biochimico Italiano, S.P.A.
• Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL
  Approved: November 13, 2006 Teva Pharmaceuticals USA
• Thallous Chloride Tl-201 Injection USP, 2 mCi/mL
  Approved: November 9, 2006 TCI Medical, Inc.
• Promethazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/mL; 1 mL ampules
  Approved: Approved: November 8, 2006 Sandoz Canada, Inc.
• Meloxicam Tablets, 7.5 mg and 15 mg
  Approved: November 7, 2006 Taro Pharmaceutical Industries, Ltd.
• Doxycycline Tablets 50 mg, 75 mg, and 100 mg
  Approved: November 7, 2006 Mylan Pharmaceuticals, Inc.
• Hydrocodone Bitartrate and Ibuprofen Tablets 5 mg/200 mg, 7.5 mg/200 mg and 10 mg/200 mg
  Approved: November 6, 2006 Vintage Pharmaceuticals, LLC
• Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg and 50 mg
  Approved: November 1, 2006 Impax Laboratories, Inc.

October

First Time Generic Approvals

• Metronidazole Vaginal Gel, 0.75%
  Approved: October 31, 2006 QLT USA, Inc.
  Generic for: Metrogel Vaginal Gel
• Colestipol Hydrochloride Tablets, 1 g
  Approved: October 24, 2006 Impax Laboratories, Inc.
  Generic for: Colestid Tablets

Other Generic Approvals

• Milrinone Lactate Injection, 1 mg (base)/mL; 5 mL Syringe
  Approved: October 31, 2006 Gland Pharma Limited
• Nicotine Polacrilex Gum USP, (Mint-Flavor) OTC 2 mg and 4 mg (base)/piece
  Approved: October 30, 2006 Perrigo R&D Company
• Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL
  Approved: October 27, 2006 Sicor Pharmaceuticals, Inc.
• Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
  Approved: October 26, 2006 Taro Pharmaceuticals U.S.A., Inc.
• Pravastatin Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: October 23, 2006 Watson Laboratories, Inc., Genpharm Inc., Cobalt Pharmaceuticals, Inc., Dr. Reddy’s Laboratories Limited, Lek Pharmaceuticals d.d., Apotex Inc.
• Zonisamide Capsules, 25 mg, 50 mg, and 100 mg
  Approved: October 16, 2006 Zydus Pharmaceuticals USA,Inc.
• Cefadroxil for Oral Suspension USP, 250 mg/5 mL and 500 mg/5 mL
  Approved: October 16, 2006 Orchid Healthcare
• Valproic Acid Syrup (Valproic Acid Oral Solution, USP), 250 mg/5 mL
  Approved: October 13, 2006 Vintage Pharmaceuticals, LLC
• Ranitidine Tablets USP, 150 mg and 300 mg
  Approved: October 13, 2006 Interpharm Inc.
• Gabapentin Tablets, 100 mg, 300 mg, and 400 mg
  Approved: October 10, 2006 Apotex Inc.
• Ribavirin Tablets, 200 mg
  Approved: October 3, 2006 Sandoz Inc.
• Citalopram Hydrobromide Tablets, 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: October 3, 2006 Invagen Pharmaceuticals, Inc.
• Meloxicam Tablets, 7.5 mg and 15 mg
  Approved: October 2, 2006 Aurobindo Pharma Limited

September

First Time Generic Approvals

• Famotidine Tablets USP, (OTC) 20 mg
  Approved: September 25, 2006 Perrigo R&D Company, Dr Reddy’s Laboratories Limited
  Generic for: Pepcid AC Tablets 20 mg
• Caffeine Citrate Oral Solution USP, 20 mg/mL; 3 mL vials
  Approved: September 21, 2006 Pharmaforce Inc.
  Generic for: Cafcit Oral Solution
• Caffeine Citrate Injection USP, 20 mg/mL; 3 mL single-dose vials
  Approved: September 21, 2006 Pharmaforce Inc.
  Generic for: Cafcit Injection
• Prednicarbate Cream, 0.1% (Emollient) 0.1%
  Approved: September 19, 2006 Altana Inc.
  Generic for: Dermatop Emollient Cream, 0.1%
• Diltiazem Hydrochloride Extended-Release Capsules USP, (once-a-day dosage) 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, and 420 mg
  Approved: September 12, 2006 K V Pharmaceutical Company
  Generic for: Tiazac Extended-Release Capsules
• Topiramate Tablets 25 mg, 100 mg, and 200 mg
  Approved: September 11, 2006 Mylan Pharmaceuticals, Inc.
  Generic for: Topamax Tablets
• Loperamide Hydrochloride and Simethicone Tablets, (OTC) 2 mg/125 mg
  Approved: September 6, 2006 Ranbaxy Laboratories Limited
  Generic for: Imodium Advanced Caplets (OTC)
• Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg
  Approved: September 6, 2006 Watson Laboratories, Inc.
  Generic for: Seasonale Tablets, 0.15 mg/0.03 mg

Other Generic Approvals

• Zonisamide Capsules 25 mg and 50 mg
  Approved: September 29, 2006 Dr. Reddy’s Laboratories Limited
• Carboplatin Injection 10 mg/mL; 5 mL, 15 mL, and 45 mL multiple-dose vials
  Approved: September 29, 2006 Dabur Oncology plc
• Oxycodone Hydrochloride and Acetaminophen Oral Solution 5 mg/325 mg per 5 mL
  Approved: September 29, 2006 Tyco Healthcare Mallinckrodt
• Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg
  Approved: September 27, 2006 Lupin Limited
• Polyethylene Glycol 3350 NF Powder For Oral Solution 17 grams/scoopful
  Approved: September 27, 2006 YVR Therapeutics, LLC
• Naproxen Sodium & Pseudoephedrine HCl Extended-Release Tablets 220 mg/120 mg; (OTC)
  Approved: September 27, 2006 Dr. Reddy’s Laboratories Limited
• Bupivacaine HCl & Epinephrine Injection USP, 0.5%/1:200,000; Packaged In 1.8 mL cartridges
  Approved: September 27, 2006 Septodont Inc.
• Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets 712.8 mg/60 mg/32 mg
  Approved: September 22, 2006 West-Ward Pharmaceutical Corp.
• Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg
  Approved: September 18, 2006 OHM Laboratories, Inc.
• Cefadroxil Capsules USP, 500 mg and 1 gram
  Approved: September 18, 2006 Orchid Healthcare
• Azithromycin for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL
  Approved: September 18, 2006 Sandoz Inc.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: September 13, 2006 Apotex Inc.
• Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg
  Approved: September 13, 2006 Unique Pharmaceutical Laboratories
• Phenytoin Sodium Injection USP, 50 mg/mL; 2 mL and 5 mL vials
  Approved: September 13, 2006 Hikma Farmaceutica (Portugal), S.A.
• Midodrine Hydrochloride Tablets 2.5 mg, 5 mg, and 10 mg
  Approved: September 12, 2006 Apotex Corp.
• Ceftriaxone for Injection USP, 10 grams/vial; (Pharmacy Bulk Package)
  Approved: September 12, 2006 Lupin Limited
• Halobetasol Propionate Ointment 0.05%
  Approved: September 7, 2006 G & W Laboratories, Inc.
• Extended Phenytoin Sodium Capsules USP 100 mg
  Approved: September 5, 2006 Taro Pharmaceutical Industries, Ltd.

August

First Time Generic Approvals

• Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg
  Approved: August 30, 2006 Teva Pharmaceuticals USA
  Generic for: Lamictal Tablets
• Ciprofloxacin Injection USP, 10 mg/mL; 1200 mg/120 mL single-use vial; Pharmacy Bulk Package
  Approved: August 28, 2006 Bedford Laboratories
  Generic for: Cipro I.V. Injection
• Ciprofloxacin Injection USP, 10 mg/mL; packaged in 200 mg/20 mL and 400 mg/40 mL single-dose vials
  Approved: August 28, 2006 Bedford Laboratories; Hospira Inc.; Sicor Pharmaceuticals, Inc.; Abraxis Pharmaceutical Products
  Generic for: Cipro I.V. Injection
• Venlafaxine Hydrochloride Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base)
  Approved: August 3, 2006 Teva Pharmaceuticals USA
  Generic for: Effexor Tablets
• Trimipramine Maleate Capsules 25 mg (base), 50 mg (base), and 100 mg (base)
  Approved: August 2, 2006 Amide Pharmaceutical, Inc.
  Generic for: Surmontil Capsules

Other Generic Approvals

• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: August 31, 2006 Cobalt Pharmaceuticals, Inc.
• Glycopyrrolate Tablets 1 mg and 2 mg
  Approved: August 31, 2006 Kali Laboratories, Inc.
• Cefotaxime for Injection USP, 1 gram/vial
  Approved: August 29, 2006 Wockhardt Limited
• Spironolactone Tablets USP, 25 mg, 50 mg, and 100 mg
  Approved: August 29, 2006 Vintage Pharmaceuticals, LLC
• Metoclopramide Tablets USP, 5 mg and 10 mg
  Approved: August 28, 2006 Vintage Pharmaceuticals, LLC
• Citalopram Hydrobromide Oral Solution 10 mg (base)/5 mL
  Approved: August 28, 2006 Aurobindo Pharma Limited
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg
  Approved: August 28, 2006 Interpharm Inc.
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 5 mg/500 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/325 mg, 10 mg/650 mg
  Approved: August 25, 2006 Interpharm Inc.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: August 24, 2006 Sun Pharmaceutical Industries Ltd.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: August 24, 2006 Sun Pharmaceutical Industries Ltd.
• Metformin Hydrochloride Tablets USP, 500 mg, 850 mg, and 1000 mg
  Approved: August 23, 2006 Dr. Reddy’s Laboratories Ltd.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: August 18, 2006 Glenmark Pharmaceuticals Limited
• Nystatin Topical Powder USP, 100,000 Units/gram
  Approved: August 18, 2006 KV Pharmaceutical Company
• Norgestimate and Ethinyl Estradiol Tablets 0.25 mg/0.035 mg, Packaged in a 28-Day Cycle Regimen
  Approved: August 17, 2006 Watson Laboratories, Inc.
• Norgestimate and Ethinyl Estradiol Tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg, respectively; Packaged in a 28-Day Cycle Regimen
  Approved: August 17, 2006 Watson Laboratories, Inc.
• Zonisamide Capsules 25 mg, 50 mg, and 100 mg
  Approved: August 16, 2006 Banner Pharmacaps, Inc.
• Baclofen Tablets USP, 10 mg and 20mg
  Approved: August 14, 2006 Caraco Pharmaceutical Laboratories, Ltd.
• Fosinopril Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: August 14, 2006 Genpharm Inc.
• Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg/30 mg (OTC)
  Approved: August 14, 2006 Dr. Reddy’s Laboratories Limited
• Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), and 100 mg (base)
  Approved: August 11, 2006 Teva Pharmaceuticals USA
• Cefotaxime for Injection USP, 500 mg (base)/vial, 1 g (base)/vial, and 2 g (base)/vial
  Approved: August 11, 2006 Orchid Healthcare
• Cefotaxime for Injection USP, 1 g (base)/vial and 2 g (base)/vial Packaged in Infusion Bottles
  Approved: August 10, 2006 Orchid Healthcare
• Cefotaxime for Injection USP, 10 g (base)/vial (Pharmacy Bulk Package)
  Approved: August 10, 2006 8/10/2006
• Testosterone Cypionate Injection USP, 100 mg/mL and 200 mg/mL
  Approved: August 10, 2006 Sandoz Canada, Inc.
• Fentanyl Transdermal System 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour
  Approved: August 4, 2006 Lavipharm Laboratories, Inc.
• Flunisolide Nasal Solution USP, 0.025% (0.025 mg/Spray) Metered Nasal Spray
  Approved: August 3, 2006 Q-Pharma LLC

July

First Time Generic Approvals

• Metoprolol Succinate Extended-Release Tablets USP 25 mg
  Approved: July 31, 2006 Sandoz Inc.
  Generic for: Toprol-XL Extended Release Tablets
• Finasteride Tablets USP 1 mg
  Approved: July 28, 2006 Dr. Reddy’s Laboratories Limited
  Generic for: Propecia Tablets
• Estradiol Transdermal System 0.0375 mg/24 hours and 0.06 mg/24 hours (Additional Strengths)
  Approved: July 20, 2006 Mylan Technologies, Inc.
  Generic for: Climara Transdermal System
• Meloxicam Tablets 7.5 mg and 15 mg
  Approved: July 19, 2006 Breckenridge Pharmaceutical, Inc., Corepharma LLC, Caraco Pharmaceutical Laboratories, Ltd., Lupin Limited, Mylan Pharmaceuticals, Inc., Watson Laboratories, Inc., Zydus Pharmaceuticals USA, Inc., Roxane Laboratories, Inc., Teva Pharmaceuticals, USA, Glenmark Pharmaceuticals Ltd., Par Pharmaceutical, Mutual Pharmaceutical Company, Inc., Actavis Totowa LLC, Lupin Limited
  Generic for: Mobic Tablets
• Azithromycin for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL
  Approved: July 5, 2006 Pliva, Inc.
  Generic for: Zithromax for Oral Suspension

Other Generic Approvals

• Alprazolam Extended-Release Tablets 0.5 mg, 1 mg, 2 mg, and 3 mg
  Approved: July 31, 2006 Barr Laboratories, Inc.
• Promethazine Hydrochloride Tablets USP, 25 mg and 50 mg
  Approved: July 31, 2006 KVK-Tech, Inc.
• Metformin Hydrochloride Tablets USP, 500 mg, 850 mg, and 1000 mg
  Approved: July 28, 2006 Amneal Pharmaceuticals LLC
• Neomycin Sulfate Tablets USP, 500 mg [350 mg (Base)]
  Approved: July 28, 2006 X-Gen Pharmaceuticals, Inc.
• Ursodiol Capsules USP 300 mg
  Approved: July 27, 2006 Corepharma LLC
• Gemfibrozil Tablets USP 600 mg
  Approved: July 27, 2006 Invagen Pharmaceuticals, Inc.
• Primidone Tablets USP 50 mg and 250 mg
  Approved: July 27, 2006 West-Ward Pharmaceutical Corp.
• Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
  Approved: July 26, 2006 Barr Laboratories, Inc.
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Approved: July 26, 2006 Synovics Laboratories, Inc.
• Meloxicam Tablets 7.5 mg and 15 mg
  Approved: July 25, 2006 Dr. Reddy’s Laboratories Limited
• Erythromycin Pledgets USP, 2%
  Approved: July 25, 2006 Altana Inc.
• Ampicillin and Sulbactam for Injection USP 1.5 g, 3 g (and 5 g, 10 g Pharmacy Bulk Package)
  Approved: July 25, 2006 Sandoz Inc.
• Meloxicam Tablets 7.5 mg and 15 mg
  Approved: July 20, 2006 Apotex Inc., Genpharm Inc.
• Metronidazole Topical Gel USP, 0.75%
  Approved: July 18, 2006 Taro Pharmaceutical Industries Ltd.
• Promethazine Hydrochloride Tablets USP, 12.5 mg, 25 mg, and 50 mg
  Approved: July 18, 2006 Vintage Pharmaceuticals, LLC
• Metronidazole Topical Gel USP, 0.75%
  Approved: July 13, 2006 QLT USA, Inc.
• Terconazole Vaginal Suppositories 80 mg
  Approved: July 12, 2006 Altana Inc.
• Glipizide Tablets USP 5 mg and 10 mg
  Approved: July 11, 2006 Caraco Pharmaceutical Laboratories, Ltd.
• Cephalexin for Oral Suspension USP 125 mg/5 mL and 250 mg/5 mL
  Approved: July 10, 2006 Orchid Healthcare
• Gabapentin Tablets 600 mg and 800 mg
  Approved: July 6, 2006 Sandoz Inc.
• Fosinopril Sodium and Hydrochlorothiazide 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: July 5, 2006 Teva Pharmaceuticals USA
• Amiodarone Hydrochloride Injection 50 mg/mL; 3 mL Ampules
  Approved: July 5, 2006 Akorn Inc.
• Warfarin Sodium Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg
  Approved: July 5, 2006 Pliva Inc.
• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: July 3, 2006 Mutual Pharmaceutical Company, Inc.

June

First Time Generic Approvals

• Sertraline Hydrochloride Oral Concentrate 20 mg (base)/mL
  Approved: June 30, 2006 Roxane Laboratories, Inc.
  Generic for: Zoloft Oral Concentrate
• Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), and 100 mg (base)
  Approved: June 30, 2006 IVAX Pharmaceuticals, Inc.
  Generic for: Zoloft Tablets
• Tranylcypromine Sulfate Tablets 10 mg (base)
  Approved: June 29, 2006 Kali Laboratories, Inc.
  Generic for: Parnate Tablets, 10 mg
• Loratadine Oral Solution USP, (OTC) 5 mg/5 mL
  Approved: June 29, 2006 Silarx Pharmaceuticals, Inc.
  Generic for: Claritin Hives Relief Syrup
• Simvastatin Tablets USP 5 mg, 10 mg, 20 mg and 40 mg
  Approved: June 23, 2006 IVAX Pharmaceuticals, Inc.
  Generic for: Zocor Tablets
• Simvastatin Tablets USP 80 mg
  Approved: June 23, 2006 Ranbaxy Inc.
  Generic for: Zocor Tablets
• Lamotrigine Tablets (Chewable) 5 mg and 25 mg
  Approved: June 21, 2006 Teva Pharmaceuticals USA
  Generic for: Lamictal Tablets (Chewable, Dispersible)
• Finasteride Tablets USP, 5 mg
  Approved: June 19, 2006 IVAX Pharmaceuticals, Inc.
  Generic for: Proscar Tablets
• Potassium Citrate Extended-Release Tablets USP, 5 mEq and 10 mEq
  Approved: June 8, 2006 Corepharma, LLC
  Generic for: Urocit-K
• Metronidazole Topical Gel 0.75%
  Approved: June 6, 2006 Altana Inc.
  Generic for: Metrogel Topical Gel

Other Generic Approvals

• Alprazolam Extended-Release Tablets 0.5 mg, 1 mg, 2 mg, and 3 mg
  Approved: June 30, 2006 Sandoz Inc.
• Fluticasone Propionate Cream 0.05%
  Approved: June 30, 2006 G & W Laboratories, Inc.
• Cefprozil for Oral Suspension USP 125 mg/5 mL and 250 mg/5 mL
  Approved: June 30, 2006 Ranbaxy Laboratories Limited
• Ceftriaxone for Injection USP 1 g/100 mL and 2 g/100 mL
  Approved: June 29, 2006 Teva Pharmaceuticals USA
• Clonazepam Tablets USP 0.5 mg, 1 mg, and 2 mg
  Approved: June 28, 2006 Vintage Pharmaceuticals, LLC
• Cyproheptadine Hydrochloride Syrup USP, 2 mg/5 mL
  Approved: June 28, 2006 Lyne Laboratories
• Anagrelide Hydrochloride Capsules 0.5 mg (base) and 1 mg (base)
  Approved: June 27, 2006 Alphapharm Pty, Ltd.
• Nortriptyline Hydrochloride Oral Solution USP, 10 mg (base)/5 mL
  Approved: June 20, 2006 Taro Pharmaceutical Industries, Ltd.
• Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg
  Approved: June 20, 2006 Lupin Limited
• Mometasone Furoate Ointment USP, 0.1%
  Approved: June 20, 2006 G & W Laboratories, Inc.
• Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL
  Approved: June 19, 2006 Hikma Pharmaceuticals
• Amoxicillin for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: June 19, 2006 Hikma Pharmaceuticals
• Citalopram Hydrobromide Oral Solution 10 mg (base)/5 mL
  Approved: June 14, 2006 Silarx Pharmaceuticals, Inc.
• Testosterone Enanthate Injection USP, 200 mg/mL; 5 mL Multiple-Dose Vials
  Approved: June 14, 2006 Paddock Laboratories, Inc.
• Triamcinolone Acetonide Cream USP, 0.025% and 0.1%
  Approved: June 9, 2006 Vintage Pharmaceuticals, LLC
• Metformin Hydrochloride Tablets USP 500 mg, 850 mg, and 1000 mg
  Approved: June 5, 2006 Interpharm, Inc.

May

First Time Generic Approvals

• Cefdinir For Oral Suspension 125 mg/5 mL
  Approved: May 31, 2006 Lupin Pharmaceuticals Inc.
  Generic for: Omnicef For Oral Suspension, 125 mg/5 mL
• Metronidazole Topical Lotion 0.75%
  Approved: May 24, 2006 Altana Inc.
  Generic for: Metrolotion Topical Lotion, 0.75%
• Escitalopram Oxalate Tablets 5 mg, 10 mg, and 20 mg
  Approved: May 22, 2006 IVAX Pharmaceuticals, Inc.
  Generic for: Lexapro Tablets
• Cefdinir Capsules, 300 mg
  Approved: May 19, 2006 Lupin Limited
  Generic for: Omnicef Capsules
• Ketotifen Fumarate Ophthalmic Solution 0.025%
  Approved: May 9, 2006 Apotex, Inc.
  Generic for: Zaditor Ophthalmic Solution
• Colestipol Hydrochloride For Oral Suspension USP, 5 g Packet or Scoopful
  Approved: May 2, 2006 Impax Laboratories, Inc.
  Generic for: Colestid

Other Generic Approvals

• Zonisamide Capsules 25 mg, 50 mg, and 100 mg
  Approved: May 31, 2006 Invagen Pharmaceuticals, Inc.
• Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg; 28-Day Regimen
  Approved: May 31, 2006 Watson Laboratories, Inc.
• Doxycycline Tablets 50 mg, 75 mg, and 100 mg
  Approved: May 31, 2006 Ranbaxy Laboratories Limited
• Nystatin Cream USP, 100,000 Units/gram
  Approved: May 31, 2006 Vintage Pharmaceuticals, LLC
• Clarithromycin Tablets USP, 250 mg and 500 mg
  Approved: May 31, 2006 Wockhardt Limited
• Warfarin Sodium Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg
  Approved: May 30, 2006 Zydus Pharmaceuticals USA, Inc.
• Cyproheptadine Hydrochloride Tablets USP, 4 mg
  Approved: May 30, 2006 Stason Pharmaceuticals, Inc.
• Polyethylene Glycol 3350 NF Powder For Oral Solution 17 grams/Scoopful
  Approved: May 26, 2006 Kali Laboratories, Inc.
• Polyethylene Glycol 3350 NF Powder For Oral Solution 17 grams/Scoopful
  Approved: May 24, 2006 Coastal Pharmaceuticals, Inc.
• Orphenadrine Citrate Injection USP, 30 mg/mL; 2 mL vials
  Approved: May 24, 2006 Akorn Inc.
• Mometasone Furoate Cream USP, 0.1%
  Approved: May 22, 2006 G&W Laboratories, Inc.
• Oxycodone and Acetaminophen Tablets USP, 2.5 mg/400 mg
  Approved: May 16, 2006 Mikart Inc.
• Ceftriaxone for Injection USP, 1 gram/vial
  Approved: May 12, 2006 Wockhardt Limited
• Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg
  Approved: May 10, 2006 Vintage Pharmaceuticals, LLC
• Polyethylene Glycol 3350 NF Powder For Oral Solution 17 g Packet or Scoopful
  Approved: May 4, 2006 Teva Pharmaceuticals USA
• Ceftriaxone for Injection USP, 10 g/vial (Pharmacy Bulk Package)
  Approved: May 1, 2006 Teva Pharmaceuticals USA
• Neomycin & Polymyxin B Sulfates & Hydrocortisone Otic Suspension 3.5 mg (Base)/10,000 U,1%/mL
  Approved: May 1, 2006 Pharmaforce, Inc.

April

First Time Generic Approvals

• Pravastatin Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: April 24, 2006 Teva Pharmaceuticals USA
  Generic for: Pravachol Tablets
• Oxycodone and Acetaminophen Tablets USP, 10 mg/650 mg
  Approved: April 19, 2006 Mikart Inc.
  Generic for: Percocet Tablets 10 mg/650 mg
• Benzphetamine HCl Tablets 50 mg
  Approved: April 17, 2006 Paddock Laboratories Inc.
  Generic for: Didrex Tablets
• Mitoxantrone Injection USP, (Concentrate) 2 mg/mL; Packaged in 20 mg/10 mL, 25 mg/12.5 mL, and 30 mg/15 mL Multiple-Dose Vials
  Approved: April 11, 2006 Bedford Laboratories, Mayne Pharma (USA) Inc., Sicor Pharmaceuticals, Inc., American Pharmaceutical Partners, Inc.
  Generic for: Novantrone Injection

Other Generic Approvals

• Oxycodone and Acetaminophen Tablets USP, 5 mg/400 mg, 7.5 mg/400 mg, 10 mg/400 mg
  Approved: April 27, 2006 Mikart Inc.
• Promethazine Hydrochloride Syrup USP, 6.25 mg/5 mL
  Approved: April 26, 2006 Vintage Pharmaceuticals, LLC
  
• Isradipine Capsules USP, 2.5 mg and 5 mg
  Approved: April 24, 2006 Amide Pharmaceutical, Inc.
• Theophylline Extended-Release Tablets 400 mg and 600 mg
  Approved: April 21, 2006 Nostrum Pharmaceuticals, Inc.
• Dipyridamole Tablets USP, 25 mg, 50 mg, and 75 mg
  Approved: April 21, 2006 Amide Pharmaceutical, Inc.
• Zonisamide Capsules 25 mg, 50 mg, and 100 mg
  Approved: April 20, 2006 Watson Laboratories, Inc.
• Cilostazol Tablets 50 mg and 100 mg
  Approved: April 20, 2006 Mylan Pharmaceuticals, Inc.
• Cyclobenzaprine Hydrochloride Tablets USP, 5 mg and 10 mg
  Approved: April 19, 2006 Jubilant Pharmaceuticals, Inc.
• Lovastatin Tablets USP, 10 mg, 20 mg, and 40 mg
  Approved: April 14, 2006 Mutual Pharmaceutical Company, Inc.
• Fexofenadine Hydrochloride Tablets 30 mg, 60 mg and 180 mg
  Approved: April 11, 2006 Dr Reddy’s Laboratories Inc.
• Hydrocortisone Sodium Succinate For Injection USP, 100 mg (Base)/2 mL Single-Dose Vial
  Approved: April 6, 2006 Hospira Inc.
• Albuterol Sulfate Inhalation Solution 0.083% (Base); Packaged in 2.5 mg (Base)/3 mL Unit-Dose Vials
  Approved: April 4, 2006 RxElite

March

• Pilocarpine Hydrochloride Tablets 5 mg and 7.5 mg
  Approved: March 31, 2006 Impax Laboratories, Inc.
  Generic for: Salagen Tablets
• Zidovudine Capsules USP, 100 mg
  Approved: March 27, 2006 Aurobindo Pharma Limited
  Generic for: Retrovir Capsules
• Glipizide Extended-Release Tablets 2.5 mg
  Approved: March 27, 2006 Watson Laboratories, Inc.
  Generic for: Glucotrol XL Extended-Release Tablets
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/300 mg (New Strength)
  Approved: March 24, 2006 Mikart, Inc.
  Generic for: Norco Tablets 7.5 mg/325 mg
• Terconazole Vaginal Suppositories 80 mg
  Approved: March 17, 2006 Perrigo Company
  Generic for: Terazol 3 Vaginal Suppositories

Other Generic Approvals

• Diazepam Tablets USP, 2 mg, 5 mg, and 10 mg
  Approved: March 31, 2006 Vintage Pharmaceuticals, LLC
• Citalopram Hydrobromide Tablets 10 mg, 20 mg and 40 mg
  Approved: March 31, 2006 Teva Pharmaceuticals USA
• Deferoxamine Mesylate for Injection USP, 500 mg/vial and 2 grams/vial
  Approved: March 31, 2006 Sicor Pharmaceuticals, Inc.
• Cefadroxil Tablets USP, 1 gram
  Approved: March 30, 2006 West-Ward Pharmaceutical Corp.
• Cilostazol Tablets 50 mg and 100 mg
  Approved: March 29, 2006 Mutual Pharmaceutical Company, Inc.
• Cefuroxime Axetil Tablets USP, 125 mg, 250 mg, and 500 mg
  Approved: March 29, 2006 Aurobindo Pharma Limited
• Amoxicillin Tablets USP, 875 mg
  Approved: March 29, 2006 Hikma Pharmaceuticals
• Calcitriol Capsules 0.25 mcg
  Approved: March 27, 2006 Roxane Laboratories, Inc.
• Citalopram Hydrobromide Tablets 10 mg, 20 mg and 40 mg
  Approved: March 22, 2006 Taro Pharmaceuticals USA, Inc.
• Propofol Injectable Emulsion 1% (10 mg/mL) 20 mL Single-Dose Vials and 50 mL & 100 mL Single-Patient Infusion Vials
  Approved: March 17, 2006 Hospira Inc.
• Zonisamide Capsules 25 mg, 50 mg, and 100 mg
  Approved: March 17, 2006 Sun Pharmaceutical Industries, Ltd.
• Lorazepam Tablets USP, 0.5 mg, 1 mg and 2 mg
  Approved: March 16, 2006 Mylan Pharmaceuticals, Inc.
• Mometasone Furoate Topical Solution USP, 0.1% (Lotion)
  Approved: March 15, 2006 Taro Pharmaceuticals USA, Inc.
• Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg
  Approved: March 14, 2006 Aurobindo Pharma Limited
• Brimonidine Tartrate Ophthalmic Solution 0.2%
  Approved: March 14, 2006 Akorn Inc.
• Cefoxitin For Injection USP, 1 g/50 mL and 2 g/50 mL
  Approved: March 10, 2006 B. Braun Medical, Inc.
• Benazepril Hydrochloride Tablets 5 mg, 10 mg, 20 mg, and 40 mg
  Approved: March 8, 2006 Apotex Inc.
• Desmopressin Acetate Tablets 0.1 mg and 0.2 mg
  Approved: March 7, 2006 Apotex Inc.
• Ciclopirox Olamine Cream USP, 0.77%
  Approved: March 3, 2006 Perrigo Company
• Fluticasone Propionate Ointment 0.005%
  Approved: March 3, 2006 G&W Laboratories, Inc.

February

First Time Generic Approvals

• Fluticasone Propionate Nasal Spray 0.05 mg (50 mcg)/ Spray
  Approved: February 22, 2006 Roxane Laboratories, Inc.
  Generic for: Flonase Nasal Spray
• Cyclobenzaprine Hydrochloride Tablets USP, 5 mg (New Strength)
  Approved: February 3, 2006 Sandoz Inc., Mylan Pharmaceuticals, Inc., Amide Pharmaceutical, Inc., Watson Laboratories, Inc.
  Generic for: Flexeril Tablets
• Cyclobenzaprine Hydrochloride Tablets USP, 7.5 mg (New Strength)
  Approved: February 3, 2006 Watson Laboratories, Inc.
  Generic for: Flexeril Tablets

January

First Time Generic Approvals

• Nicotine Polacrilex Lozenges 2 mg and 4 mg
  Approved: January 31, 2006 Perrigo R&D Company
  Generic for: Commit
• Testosterone Gel 1%
  Approved: January 27, 2006 Watson Laboratories, Inc.
  Generic for: AndroGel
• Alprazolam Extended-Release Tablets 0.5 mg, 1 mg, 2 mg, and 3 mg
  Approved: January 26, 2006 Mylan Pharmaceuticals, Inc.
  Generic for: Xanax XR
• Clopidogrel Bisulfate Tablets 75 mg
  Approved: January 20, 2006 Apotex Corporation
  Generic for: Plavix Tablets
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg
  Approved: January 19, 2006 Mikart, Inc.
  Generic for: Norco Tablets
• Isradipine Capsules USP, 2.5 mg and 5 mg
  Approved: January 5, 2006 Abrika Pharmaceuticals
  Generic for: Dynacirc Capsules

December

First Time Generic Approvals

• Cabergoline Tablets 0.5 mg
  Approved: December 29, 2005 Par Pharmaceutical, Inc.
  Generic for: Dostinex Tablets
• Zonisamide Capsules 25 mg, 50 mg and 100 mg
  Approved: December 22, 2005 Alphapharm Pty Ltd; Teva Pharmaceuticals USA; Apotex Inc.; Sandoz Inc.; Barr Laboratories, Inc.; Roxane Laboratories, Inc.; Dr. Reddy’s Laboratories Limited (100 mg only); Wockhardt Limited (100 mg only); Mylan Pharmaceuticals, Inc.; Mutual Pharmaceutical Company, Inc.
  Generic for: Zonegran Capsules
• Azithromycin for Injection 500 mg/vial
  Approved: December 13, 2005 American Pharmaceutical Partners, Inc.
  Generic for: Zithromax For Injection
• Cefprozil For Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: December 8, 2005 Teva Pharmaceuticals USA; Sandoz Inc.
  Generic for: Cefzil For Oral Suspension
• Ribavirin Tablets 200 mg, 400 mg and 600 mg
  Approved: December 5, 2005 Three Rivers Pharmaceuticals, LLC; Zydus Pharmaceuticals USA, Inc. (200 mg only); Teva Pharmaceuticals, Inc. (200 mg only)
  Generic for: Copegus Tablets

Other Generic Approvals

• Cefprozil for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: December 30, 2005 Orchid Healthcare
• Oxycodone and Acetaminophen Tablets USP, 2.5 mg/300 mg, 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg
  Approved: December 30, 2005 Mikart Inc.
• Fenofibrate Tablets 107 mg
  Approved: December 29, 2005 Par Pharmaceutical, Inc.
• Glimepiride Tablets 1 mg, 2 mg, 4 mg, and 8 mg
  Approved: December 23, 2005 Par Pharmaceutical Inc.
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Approved: December 21, 2005 Mutual Pharmaceutical Company, Inc.
• Doxycycline Hyclate Delayed-Release Capsules USP 75 mg (Base) and 100 mg (Base)
  Approved: December 21, 2005 Sandoz Inc.
• Baclofen Tablets USP 20 mg
  Approved: December 20, 2005 Lannett Holdings, Inc.
• Methylprednisolone Sodium Succinate For Injection USP, 40 mg (Base)/Fliptop Vial and 125 mg (Base)/Fliptop Vial
  Approved: December 20, 2005 Hospira Inc.
• Ranitidine Tablets USP, 150 mg and 300 mg
  Approved: December 19, 2005 Cobalt Pharmaceuticals, Inc.
• Cefprozil Tablets USP, 250 mg and 500 mg
  Approved: December 19, 2005 Orchid Healthcare
• Cefprozil For Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: December 19, 2005 Lupin Limited
• Tramadol Hydrochloride and Acetaminophen Tablets, 37.5 mg/325 mg
  Approved: December 16, 2005 Caraco Pharmaceutical Laboratories Ltd.
• Clozapine Tablets USP, 50 mg, 100 mg, and 200 mg
  Approved: December 16, 2005 Goldline Laboratories, Inc.
• Bisoprolol Fumarate Tablets 5 mg and 10 mg
  Approved: December 14, 2005 Mylan Pharmaceuticals, Inc.
• Mirtazapine Orally Disintegrating Tablets 15 mg and 30 mg
  Approved: December 8, 2005 Aurobindo Pharma Limited
• Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
  Approved: Approved: December 8, 2005 KV Pharmaceutical Company
• Doxycycline Tablets 50 mg and 100 mg
  Approved: December 8, 2005 Lannett Holdings, Inc.
• Cefprozil Tablets USP, 250 mg and 500 mg
  Approved: December 8, 2005 Lupin Limited
• Carbamazepine Tablets USP, 100 mg, 200 mg, 300 mg, and 400 mg
  Approved: December 7, 2005 Caraco Pharmaceutical Laboratories, Ltd.
• Oxycodone Hydrochloride Extended-Release Tablets 10 mg, 20 mg, and 40 mg
  Approved: December 6, 2005 Teva Pharmaceuticals, USA; Impax Laboratories, Inc.
• Cefprozil Tablets USP, 250 mg and 500 mg
  Approved: December 6, 2005 Teva Pharmaceuticals USA

November

First Time Generic Approvals

• Ofloxacin Otic Solution, 0.3%
  Approved: November 18, 2005 Apotex Inc.
  Generic for: Floxin Otic Solution
• Azithromycin Tablets 250 mg,500 mg and 600 mg
  Approved: November 14, 2005 Teva Pharmaceuticals USA; Sandoz, Inc.
  Generic for: Zithromax Tablets
• Cefprozil Tablets USP, 250 mg and 500 mg
  Approved: November 14, 2005 Sandoz Inc.
  Generic for: Cefzil Tablets

Other Generic Approvals

• Flavoxate Hydrochloride Tablets, 100 mg
  Approved: November 30, 2005 Hampton Laine, LLC
• Mupirocin Ointment USP, 2%
  Approved: November 30, 2005 Altana Inc.
• Ampicillin and Sulbactam for Injection USP, 1 g/500 mg; 2 g/1 g
  Approved: November 30, 2005 G.C. Hanford Manufacturing Company
• Chlorhexidine Gluconate Oral Rinse USP, 0.12%
  Approved: November 29, 2005 John O. Butler Company
• Ampicillin and Sulbactam for Injection USP, 1 g/500 mg; 2 g/1 g
  Approved: November 29, 2005 Instituto Biochimico Italiano, S.P.A.
• Glimepiride Tablets 1 mg, 2 mg, and 4 mg
  Approved: November 28, 2005 Mylan Pharmaceuticals, Inc.
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Approved: November 25, 2005 Barr Laboratories, Inc.
• Cephalexin Capsules USP, 250 mg and 500 mg
  Approved: November 25, 2005 Lupin Limited
• Ampicillin and Sulbactam For Injection USP, 10 g/5 g
  Approved: November 25, 2005 G.C. Hanford Manufacturing Company
• Nifedipine Extended-Release Tablets USP, 30 mg and 60 mg
  Approved: November 21, 2005 Osmotica Pharmaceutical Corporation
• Octreotide Acetate Injection, 0.2 mg/mL and 1 mg/mL; 5 mL vials
  Approved: November 21, 2005 Sicor Pharmaceuticals, Inc.
• Promethazine Hydrochloride Tablets USP, 12.5 mg, 25 mg, and 50 mg
  Approved: November 18, 2005 Zydus Pharmaceuticals USA, Inc.
• Cephalexin Capsules USP, 250 mg and 500 mg
  Approved: November 16, 2005 Aurobindo Pharma Limited
• Citalopram Hydrobromide Oral Solution, 10 mg/5 mL
  Approved: November 15, 2005 Apotex Inc.
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: November 10, 2005 Lannett Holdings, Inc.
• Sodium Bicarbonate Injection USP, 7.5% (0.9 Meq/mL) and 8.4% (1 Meq/mL) syringes
  Approved: November 9, 2005 Hospira, Inc.
• Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg
  Approved: November 9, 2005 KV Pharmaceutical Company
• Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg
  Approved: November 9, 2005 Excellium Pharmaceutical, Inc.
• Amoxicillin Capsules USP, 250 mg and 500 mg
  Approved: November 9, 2005 Aurobindo Pharma Limited
• Amoxicillin Tablets USP, 500 mg and 875 mg
  Approved: November 9, 2005 Aurobindo Pharma Limited
• Cilostazol Tablets, 50 mg
  Approved: November 8, 2005 Sandoz Inc.
• Sotalol Hydrochloride Tablets USP 80 mg, 120 mg, and 160 mg
  Approved: November 4, 2005 Genpharm Inc.

October

First Time Generic Approvals

• Glipizide and Metformin Hydrochloride Tablets 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg
  Approved: October 27, 2005 Corepharma LLC
  Generic for: Metaglip Tablets
• Ramipril Capsules 1.25 mg, 2.5 mg, 5 mg, and 10 mg
  Approved: October 24, 2005 Cobalt Pharmaceuticals, Inc.
  Generic for: Altace Capsules
• Glimepiride Tablets 1 mg, 2 mg, and 4 mg
  Approved: October 6, 2005 Corepharma LLC; Dr. Reddy’s Laboratories Limited; Invagen Pharmaceuticals, Inc.; Teva Pharmaceuticals USA
  Generic for: Amaryl Tablets
• Glimepiride Tablets 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg
  Approved: October 6, 2005 Ranbaxy Laboratories, Inc.
  Generic for: Amaryl Tablets
• Amlodipine Besylate Tablets 2.5 mg (Base), 5 mg (Base), and 10 mg (Base)
  Approved: October 3, 2005 Mylan Pharmaceuticals, Inc.
  Generic for: Norvasc Tablets

Other Generic Approvals

• Citalopram Hydrobromide Tablets 10 mg (Base), 20 mg (Base), and 40 mg (Base)
  Approved: October 31, 2005 Pliva Hrvatska D.O.O.
• Fenofibrate Tablets 54 mg, 107 mg, and 160 mg
  Approved: October 31, 2005 Ranbaxy Laboratories Limited
• Neomycin & Polymyxin B Sulfates & Hydrocortisone Otic Sol 3.5 mg (Base)/10,000U/10 mg per mL
  Approved: October 31, 2005 Pharmaforce, Inc.
• Glipizide and Metformin Hydrochloride Tablets 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg
  Approved: October 28, 2005 Teva Pharmaceuticals USA
• Ribavirin Capsules 200 mg
  Approved: October 28, 2005 Zydus Pharmaceuticals USA Inc.
• Clotrimazole Lozenges USP, 10 mg
  Approved: October 28, 2005 Paddock Laboratories, Inc.
• Neomycin & Polymyxin B Sulfates & Gramicidin Ophthalmic Sol 1.75 mg(Base)/10,0000 Units/0.025 mg per mL
  Approved: October 28, 2005 Pharmaforce, Inc.
• Dantrolene Sodium Capsules 25 mg, 50 mg, and 100 mg
  Approved: October 24, 2005 Amide Pharmaceutical, Inc.
• Hydromorphone Hydrochloride Tablets USP, 8 mg
  Approved: October 18, 2005 Amide Pharmaceutical, Inc.
• Clarithromycin Tablets USP, 250 mg
  Approved: October 18, 2005 Sandoz Inc.
• Pilocarpine Hydrochloride Tablets 5 mg
  Approved: October 14, 2005 Lannett Holdings, Inc.
• Ketorolac Tromethamine Injection USP, 30 mg/mL; packaged 5 Ml Multiple-Dose Vials
  Approved: October 14, 2004 Apotex Inc.
• Sulfamethoxazole And Trimethoprim Tablets USP, 400 mg/80 mg and 800 mg/160 mg
  Approved: October 7, 2005 Vista Pharmaceuticals, Inc.
• Gabapentin Capsules 100 mg, 300 mg and 400 mg
  Approved: October 7, 2005 Ranbaxy Laboratories Limited
• Glimepiride Tablets 1 mg, 2 mg, and 4 mg
  Approved: October 6, 2005 Teva Pharmaceuticals USA
• Cyclobenzaprine Hydrochloride Tablets USP, 10 mg
  Approved: October 4, 2005 Amide Pharmaceutical, Inc.
• Octreotide Acetate Injection 0.05 mg (Base)/mL, 0.1 mg(Base)/mL, and 0.5 mg (Base)/mL
  Approved: October 3, 2005 Sicor Pharmaceuticals, Inc.

September

First Time Generic Approvals

• Zidovudine Oral Solution USP, 50 mg/5 mL
  Approved: September 19, 2005 Aurobindo Pharma Limited
  Generic for: Retrovir Syrup
• Zidovudine Tablets USP 300 mg
  Approved: September 19, 2005 Aurobindo Pharma/Roxane/Ranbaxy
  Generic for: Retrovir Tablets
• Tretinoin Cream USP (Emollient), 0.05%
  Approved: September 15, 2005 Spear Pharmaceuticals
  Generic for: Renova Cream
• Leflunomide Tablets 10 mg and 20 mg
  Approved: September 13, 2005 Barr Laboratories, Inc.
  Generic for: Arava Tablets

Other Generic Approvals

• Acyclovir Tablets USP, 400 mg and 800 mg
  Approved: September 29, 2005 Apotex Inc.
• Primidone Tablets USP, 50 mg and 250 mg
  Approved: September 29, 2005 Mutual Pharmaceutical Company, Inc.
• Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg
  Approved: September 28, 2005 Ranbaxy Laboratories Limited
• Danazol Capsules USP, 200 mg
  Approved: September 28, 2005 Lannett Holdings, Inc.
• Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: September 28, 2005 Sandoz Inc.
• Fluconazole Tablets 50 mg, 100 mg, and 200 mg
  Approved: September 28, 2005 Unique Pharmaceutical Laboratories
  
• Acyclovir Capsules USP, 200 mg
  Approved: September 28, 2005 Apotex Inc.
• Mupirocin Ointment USP, 2 %
  Approved: September 23, 2005 Taro Pharmaceuticals U.S.A., Inc.
• Carboplatin Injection 10 mg/mL; 5 mL, 15 mL, 45 mL, and 60 mL Vials
  Approved: September 21, 2005 Sicor Pharmaceuticals, Inc.
• Ergotamine Tartrate and Caffeine Tablets USP 1 mg/100 mg
  Approved: September 16, 2005 Mikart, Inc.
• Nizatidine Capsules USP, 150 mg and 300 mg
  Approved: September 15, 2005 Dr. Reddy’s Laboratories Limited
• Alclometasone Dipropionate Cream USP, 0.05%
  Approved: September 15, 2005 Taro Pharmaceuticals USA, Inc.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: September 14, 2005 Ranbaxy Laboratories Limited
• Leflunomide Tablets 10 mg and 20 mg
  Approved: September 13, 2005 Apotex/Sandoz/Kali Labs/Teva
  
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: September 13, 2005 Impax Laboratories, Inc.
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Approved: September 13, 2005 Mylan Pharmaceuticals, Inc.
• Lisinopril Tablets USP 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg
  Approved: September 9, 2005 Lupin Limited
• Midazolam Hydrochloride Syrup 2 mg (base)/mL
  Approved: September 9, 2005 Apotex Inc.
• Benazepril Hydrochloride and Hydrochlorothiazide Tablets 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg
  Approved: September 8, 2005 Ranbaxy Laboratories Limited
• Allopurinol Tablets USP 100 mg and 300 mg
  Approved: September 8, 2005 Apotex Inc.
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: September 8, 2005 Mylan Pharmaceuticals, Inc.
• Fexofenadine Hydrochloride Tablets 30 mg, 60 mg, and 180 mg
  Approved: September 1, 2005 Teva Pharmaceuticals, USA

August

First Time Generic Approvals

• Fexofenadine Hydrochloride Tablets 30 mg, 60 mg, and 180 mg
  Approved: August 31, 2005 Barr Laboratories, Inc.
  Generic for: Allegra Tablets
• Ceftriaxone Injection USP, 1 gram/50 mL and 2 grams/50 mL
  Approved: August 23, 2005 Baxter Healthcare Corporation
  Generic for: Rocephin Injection
• Liothyronine Sodium Injection 10 mcg(base)/mL; 1 mL vials
  Approved: August 17, 2005 Pharmaforce, Inc.
  Generic for: Triostat Injection
• Clonazepam Orally Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg
  Approved: August 3, 2005 Kali Laboratories, Inc.
  Generic for: Klonopin Rapidly Disintegrating Tablets

Other Generic Approvals

• Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg, and 45 mg
  Approved: August 31, 2005 Amide Pharmaceutical, Inc.
• Baclofen Tablets USP 10 mg and 20 mg
  Approved: August 30, 2005 Vintage Pharmaceuticals, LLC
• Cholestyramine for Oral Suspension USP, 4 g Resin/ 9 g Scoopful or Packet
  Approved: August 26, 2005 Par Pharmaceutical, Inc.
• Cholestyramine for Oral Suspension USP, (Light) 4 g Resin/Scoopful or Packet
  Approved: August 26, 2005 Par Pharmaceutical, Inc.
• Clarithromycin Extended-Release Tablets 500 mg
  Approved: August 25, 2005 Sandoz Inc.
• Clarithromycin Tablets USP, 500 mg
  Approved: August 25, 2005 Sandoz Inc.
• Prednisolone Syrup USP, 5 mg/5 mL and 15 mg/5 mL
  Approved: August 25, 2005 Apotex Inc.
• Fluconazole Injection (in 0.9% Sodium Chloride), 2 mg/mL; 100 mL vials
  Approved: August 23, 2005 Hikma Farmaceutica (Portugal), LDA
• Amoxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg (Base)
  Approved: August 23, 2005 Sandoz Inc.
• Phenytoin Oral Suspension USP, 125 mg/5 mL
  Approved: August 18, 2005 Vistapharm, Inc.
• Citalopram Hydrobromide Tablets 10 mg, 20 mg and 40 mg (base)
  Approved: August 17, 2005 Sandoz Inc.
• Cephalexin for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: August 17, 2005 Lupin Limited
• Fosinopril Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: August 16, 2005 Watson Laboratories, Inc.
• Paroxetine Tablets USP 10 mg, 20 mg, 30 mg, and 40 mg
  Approved: August 15, 2005 Teva Pharmaceuticals USA
• Cefazolin for Injection 1 g/vial and 10 gram/vial (Pharmacy Bulk Package)
  Approved: August 12, 2005 Orchid Healthcare
• Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg (base)
  Approved: August 12, 2005 Lannett Holdings, Inc.
• Methotrexate for Injection USP (Preservative-Free), 1 gram/vial
  Approved: August 12, 2005 Bedford Laboratories
• Clonazepam Orally Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg
  Approved: August 10, 2005 Barr Laboratories, Inc.
• Ciclopirox Topical Suspension USP (Lotion), 0.77%
  Approved: August 10, 2005 Taro Pharmaceuticals USA, Inc.
• Clobetasol Propionate Topical Solution USP, 0.05%
  Approved: August 5, 2005 QLT USA, Inc.
• Halobetasol Proprionate Cream 0.05%
  Approved: August 4, 2005 Taro Pharmaceuticals USA Inc.
• Loxapine Capsules USP, 5 mg, 10 mg, 25 mg and 50 mg (base)
  Approved: August 4, 2005 Amide Pharmaceutical, Inc.
• Hydrocortisone Butyrate Cream USP, 0.1%
  Approved: August 3, 2005 Taro Pharmaceutical Industries Ltd.
• Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial Pharmacy Bulk Package
  Approved: August 2, 2005 Orchid Healthcare

July

First Time Generic Approvals

• Rifampin and Isoniazid Capsules USP, 300 mg/150 mg
  Approved: July 29, 2005 Company: West-Ward Pharmaceutical Corp.
  Generic for: Rifamate Capsules
• Fexofenadine Hydrochloride Capsules 60 mg
  Approved: July 13, 2005 Company: Barr Laboratories, Inc.
  Generic for: Allegra Capsules
• Alclometasone Dipropionate Cream USP, 0.05%
  Approved: July 12, 2005 Company: Altana Inc.
  Generic for: Aclovate Cream
• Isoniazid Injection USP, 100 mg/mL; Packaged In 10 Ml Multiple-Dose Vials
  Approved: July 7, 2005 Company: Sabex 2002 Inc.
  Generic for: Nydrazid Injection
• Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg
  Approved: July 1, 2005 Company: Barr Laboratories, Inc.
  Generic for: DDAVP Tablets

Other Generic Approvals

• Baclofen Tablets USP, 10 mg and 20 mg
  Approved: July 29, 2005 Company: Alphapharm Pty. Ltd.
• Valproic Acid Syrup USP, 250 mg/5 mL
  Approved: July 29, 2005 Company: Apotex Inc.
• Desogestrel and Ethinyl Estradiol Tablets 0.15 mg/0.03 mg; 28-Day
  Approved: July 29, 2005 Company: Watson Laboratories, Inc.
• Cefuroxime Axetil Tablets USP, 125 mg (Base), 250 mg (Base), and 500 mg (Base)
  Approved: July 29, 2005 Company: Wockhardt Limited
• Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg
  Approved: July 29, 2005 Company: Mutual Pharmaceutical Company, Inc.
• Famotidine Tablets USP, 20 mg and 40 mg
  Approved: July 27, 2005 Company: Perrigo R&D Company
• Ranitidine Tablets USP, 150 mg and 300 mg
  Approved: July 27, 2005 Company: Dr. Reddy’s Laboratories Limited
• Folic Acid Tablets USP, 1 mg
  Approved: July 21, 2005 Company: Pharmax Group, Inc.
• Milrinone Lactate in 5% Dextrose Injection 20 mg (Base)/100 mL; 100 mL and 200 mL
  Approved: July 20, 2005 Company: Apotex Corp.
• Ipratropium Bromide Inhalation Solution 0.02%; 2.5 mL Unit-Dose Vials
  Approved: July 19, 2005 Company: Rxelite
• Ibuprofen Tablets USP, 400 mg, 600 mg, and 800 mg
  Approved: July 18, 2005 Company: Perrigo R&D Company
• Folic Acid Tablets USP, 1 mg
  Approved: July 18, 2005 Company: Mutual Pharmaceutical Company, Inc.
• Bupropion Hydrochloride Extended-Release Tablets USP, 100 mg and 150 mg
  Approved: July 14, 2005 Company: Sandoz Inc.
• Lorazepam Injection USP, 2 mg/mL and 4 mg/mL; 10 mL Multiple-Dose Vials
  Approved: July 13, 2005 Company: Bedford Laboratories
• Lorazepam Injection USP (Preservative-Free), 2 mg/mL and 4 mg/mL; 1 mL Single-Dose Vials
  Approved: July 13, 2005 Company: Bedford Laboratories
• Hydrochlorothiazide Capsules 12.5 mg
  Approved: July 13, 2005 Company: IVAX Pharmaceuticals, Inc.
• Amoxicillin Tablets USP, 500 mg and 875 mg
  Approved: July 13, 2005 Company: Sandoz Inc.
• Methadone Hydrochloride Tablets USP, Diskets, Dispersible 40 mg
  Approved: July 12, 2005 Company: Mallinckrodt Inc.
• Methimazole Tablets USP, 15 mg
  Approved: July 12, 2005 Company: Cedar Pharmaceuticals LLC
• Diphenhydramine Hydrochloride Injection USP, 50 mg/mL; 10 mL Multiple-Dose Vials
  Approved: July 12, 2005 Company: Bioniche Pharma
• Mercaptopurine Tablets USP, 50 mg
  Approved: July 1, 2005 Company: Mylan Pharmaceuticals, Inc.

June

First Time Generic Approvals

• Carbidopa and Levodopa Tablets For Oral Suspension 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg
  Approved: June 6, 2005 Company: Ranbaxy Laboratories Limited
  Generic for: Sinemet Tablets

Other Generic Approvals

• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: June 30, 2005 Company: Cobalt Pharmaceuticals, Inc.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: June 30, 2005 Comapny: Mutual Pharmaceutical Company, Inc.
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: June 29, 2005 Company: Ranbaxy Laboratories Limited
• Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/500 mg
  Approved: June 28, 2005 Company: Andrx Pharmaceuticals, LLC
  
• Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg, and 45 mg
  Approved: June 28, 2005 Company: Teva Pharmaceuticals USA
• Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg
  Approved: June 28, 2005 Company: Purepac Pharmaceutical Co.
• Cephalexin Capsules USP, 250 mg and 500 mg
  Approved: June 28, 2005 Company: Orchid Healthcare
• Nystatin Oral Suspension USP, 100,000 Units/mL
  Approved: June 28, 2005 Company: Vintage Pharmaceuticals, LLC
• Haloperidol Decanoate Injection 50 mg (base)/mL and 100 mg (base)/mL
  Approved: June 24, 2005 Company: Sabex 2002 Inc.
• Ibuprofen Tablets USP, (OTC), 200 mg Orange-Coated, Round & Capsule-Shaped
  Approved: June 21, 2005 Company: Perrigo R&D Company
• Cromolyn Sodium Inhalation Solution USP, 10 mg/mL; packaged in 20 mg/2 mL Single- Dose Ampules
  Approved: June 17, 2005 Company: Breath Limited
• Levothyroxine Sodium Tablets USP, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg
  Approved: June 16, 2005 Company: Genpharm Inc.
• Clotrimazole & Betamethasone Dipropionate Lotion USP, 1%/0.05%(base)
  Approved: June 16, 2005 Company: Altana Inc.
• Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500 mg, and 750 mg
  Approved: June 15, 2005 Company: Pliva, Inc.
• Fluticasone Propionate Ointment 0.005%
  Approved: June 14, 2005 Company: Taro Pharmaceutical Industries, Ltd.
• Halobetasol Propionate Ointment 0.05%
  Approved: June 14, 2005 Company: Alpharma USPD Inc.
• Carboplatin Injection 10 mg/mL; packaged in 50 mg/5 mL, 150 mg/15 mL, and 450 mg/45 mL Multiple-Dose Vials
  Approved: June 14, 2005 Company: Spectrum Pharmaceuticals, Inc.
• Folic Acid Tablets USP, 1 mg
  Approved: June 14, 2005 Company: Trigen Laboratories, Inc.
• Acyclovir Oral Suspension USP, 200 mg/5 mL
  Approved: June 7, 2005 Company: Hi-Tech Pharmacal Co., Inc.
• Carisoprodol Tablets USP, 350 mg
  Approved: June 7, 2005 Company: Neil Laboratories, Inc.
• Prednisone Tablets USP, 1 mg
  Approved: June 6, 2005 Company: Trigen Laboratories, Inc.
• Vinorelbine Tartrate Injection, 10 mg (base)/mL; packaged in 10 mg (base)/1 mL and 50 mg (base)/5 mL Single-Use Vials
  Approved: June 2, 2005 Company: Mayne Pharma (USA), Inc.
• Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg and 50 mg
  Approved: June 1, 2005 Company: Upsher-Smith Laboratories, Inc.

May

First Time Generic Approvals

• Foscarnet Sodium Injection 24 mg/mL; 250 mL and 500 mL Bottles
  Approved: May 31, 2005 Company: Pharmaforce, Inc.
  Generic for: Foscavir Injection
• Ceftriaxone for Injection USP, 10 g/vial (Pharmacy Bulk Package)
  Approved: May 17, 2005 Company: Sandoz, Inc.
  Generic for: Rocephin For Injection (PBP)
• Fenofibrate Tablets 54 mg and 160 mg
  Approved: May 13, 2005 Company: Teva Pharmaceuticals USA
  Generic for: Tricor Tablets
• Doxycycline Hyclate Capsules USP, 20 mg
  Approved: May 13, 2005 Company: West-Ward Pharmaceutical Corp.
  Generic for: Periostat Capsules
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Ivax Pharmaceuticals, Inc.
  Generic for: Periostat Tablets
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Mutual Pharmaceutical Company, Inc.
  Generic for: Periostat Tablets

Other Generic Approvals

• Torsemide Tablets 5 mg, 10 mg, 20 mg, and 100 mg
  Approved: May 31, 2005 Company: Apotex Inc.
• Clarithromycin Tablets USP, 250 mg and 500 mg
  Approved: May 31, 2005 Company: Teva Pharmaceuticals USA; Ivax Pharmaceuticals, Inc.
• Hydroxyzine Hydrochloride Tablets USP, 10 mg, 25 mg and 50 mg
  Approved: May 27, 2005 Company: Vintage Pharmaceuticals, LLC
• Prednisolone Sodium Phosphate Oral Solution 5 mg (base)/5 mL and 15 mg (base)/5 mL
  Approved: May 24, 2005 Company: KV Pharmaceutical Company
• Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/35 mcg; packaged in 28-day regimens
  Approved: May 23, 2005 Company: Barr Laboratories, Inc.
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, and Ferrous Fumarate Tablets 1 mg/0.02 mg/75 mg
  Approved: May 20, 2005 Company: Andrx Pharmaceuticals, LLC
• Fluoxetine Capsules USP, 40 mg
  Approved: May 18, 2005 Company: Barr Laboratories, Inc.
• Clarithromycin Extended-Release Tablets 500 mg
  Approved: May 18, 2005 Company: Teva Pharmaceuticals USA
• Cilostazol Tablets 50 mg and 100 mg
  Approved: May 17, 2005 Company: Roxane Laboratories, Inc.
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: May 17, 2005 Company: Apotex Inc.
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Corepharma LLC
• Ipratropium Bromide Inhalation Solution 0.02%; 0.5 mg/2.5 mL vials
  Approved: May 9, 2005 Company: Breath Limited
• Ceftriaxone for Injection USP, 250 mg, 500 mg, 1 g, and 2 g vials
  Approved: May 9, 2005 Company: Sandoz, Inc.
• Flumazenil Injection USP, 0.1 mg/mL; 5 mL and 10 mL vials
  Aapproved: May 3, 2005 Company: Sabex 2002 Inc.
• Ceftriaxone for Injection USP, 1 g and 2 g vials
  Approved: May 3, 2005 Company: Sandoz, Inc.
• Nystatin Topical Powder USP, 100,000 units/gram
  Approved: May 3, 2005 Company: Upsher-Smith Laboratories, Inc.
• Clonazepam Tablets USP 0.5 mg, 1 mg, and 2 mg
  Approved: May 2, 2005 Company: Kali Laboratories, Inc.
• Esmolol Hydrochloride Injection 10 mg/mL; 10 mL vials
  Approved: May 2, 2005 Company: American Pharmaceutical Partners, Inc.; Pharmaforce, Inc.
• Midazolam Hydrochloride Syrup 2 mg (base)/mL
  Approved: May 2, 2005 Company: Paddock Laboratories, Inc.

April

First Time Generic Approvals

• Estradiol and Estradiol/Norgestimate Tablets 1 mg and 1 mg/0.09 mg
  Approved: April 29, 2005 Company: Barr Laboratories, Inc.
  Generic for: Prefest Tablets
• Niacin Extended-Release Tablets 500 mg and 750 mg
  Approved: April 26, 2005 Company: Barr Laboratories, Inc.
  Generic for: Niaspan Extended-Release Tablets
• Clozapine Tablets USP 50 mg (New Strength)
  Approved: April 25, 2005 Company: Ivax Pharmaceuticals, Inc.
  Generic for: Clozaril Tablets
• Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
  Approved: April 21, 2005 Company: Kali Laboratories, Inc.
  Generic for: Ultracet Tablets
• Anagrelide Hydrochloride Capsules 0.5 mg (base) and 1 mg (base)
  Approved: April 18, 2005 Company: Impax Laboratories, Inc., Ivax Pharmaceuticals, Inc., Roxane Laboratories, Inc., Watson Laboratories, Inc., Barr Laboratories, Inc., Eon Labs, Inc., Mylan Pharmaceuticals, Inc.
  Generic for: Agrylin Capsules
• Niacin Extended-Release Tablets 1000 mg
  Approved: April 18, 2005 Company: Barr Laboratories, Inc.
  Generic for: Niaspan Tablets
• Fexofenadine HCl & Pseudoephedrine HCl ER 60 mg/120 mg
  Approved: April 14, 2005 Company: Barr Laboratories, Inc.
  Generic for: Allegra D Extended-Release Tablets
• Octreotide Acetate Injection 0.2 mg/mL (base) 1 mg/mL (base)
  Approved: April 8, 2005 Company: Bedford Laboratories
  Generic for: Sandostatin Injection
• Mometasone Furoate Topical Solution USP 0.1%
  Approved: April 6, 2005 Company: Aigis Industries Ltd.
  Generic for: Elocon Topical Lotion

Other Generic Approvals

• Citalopram Hydrobromide Tablets 10 mg, 20 mg, and 40 mg (base)
  Approved: April 29, 2005 Company: Akyma Pharmaceuticals, LLC
• Norethindrone/Ethinyl Estradiol and Ferrous Fumarate Tablets USP 1.5 mg/0.03 mg/75 mg
  Approved: April 28, 2005 Company: Andrx Pharmaceuticals, LLC
• Naproxen Tablets USP 250 mg, 375 mg, and 500 mg
  Approved: April 27, 2005 Company: Perrigo R&D Company
• Adenosine Injection USP 3 mg/mL; packaged in 6 mg/2 mL and 12 mg/4 mL single-use vials
  Approved: April 27, 2005 Company: American Pharmaceutical Partners
• Clozapine Tablets USP 25 mg and 100 mg
  Approved: April 26, 2005 Company: Teva Pharmaceuticals USA
• Prednisolone Sodium Phosphate Oral Solution 15 mg (base)/5 mL
  Approved: April 25, 2005 Company: Pharmaceutical Associates, Inc.
• Dexamethasone Sodium Phosphate Injection USP 10 mg/mL (Preserved) Multiple-Dose Vials
  Approved: April 22, 2005 Company: American Pharmaceutical Partners
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: April 21, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Cefazolin for Injection USP 500 mg/vial and 1 g/vial
  Approved: April 21, 2005 Company: Orchid Healthcare
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: April 20, 2005 Company: Invagen Pharmaceuticals, Inc.
• Amiodarone Hydrochloride Injection 50 mg/mL
  Approved: April 20, 2005 Company: Apotex Corp.
• Metformin Hydrochloride Extended-Release Tablets 500 Mg
  Approved: April 20, 2005 Company: Zydus Pharmaceuticals USA Inc.
• Propofol Injectable Emulsion 10 mg/mL; packaged in 20 mL, 50 mL, and 100 mL Single-Dose Vials
  Approved: April 19, 2005 Company: Bedford Laboratories
• Metformin Hydrochloride Tablets 500 mg, 850 mg, and 1000 mg
  Approved: April 18, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Vinorelbine Tartrate Injection 10 mg (base)/mL; packaged in 1 mL and 5 mL Single-Use Vials
  Approved: April 18, 2005 Company: American Pharmaceutical Partners
• Phentermine Hydrochloride Tablets USP 37.5 mg
  Approved: April 15, 2005 Company: Lannett Holdings, Inc.
• Metformin Hydrochloride Extended-Reaease Tablets 750 mg
  Approved: April 13, 2005 Company: Purepac Pharmaceutical Co
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: April 12, 2005 Company: Andrx Pharmaceuticals, LLC, Teva Pharmaceuticals USA
• Ciclopirox Olamine Cream USP 0.77%
  Approved: April 12, 2005 Company: Taro Pharmaceuticals USA, Inc.
• Ketoconazole Shampoo 2 %
  Approved: April 11, 2005 Company: QLT USA, Inc.
  
• Amiodarone Hydrochloride Tablets 200 mg and 400 mg
  Approved: April 8, 2005 Company: Aurosal Pharmaceuticals, LLC.
• Mometasone Furoate Cream USP 0.1%
  Approved: April 8, 2005 Company: Altana Inc.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: April 6, 2005 Company: Eon Pharma, LLC; Apotex Inc.
  
• Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
  Approved: April 5, 2005 Company: Eon Labs, Inc.
• Bromocriptine Mesylate Capsules USP 5 mg (base)
  Approved: April 4, 2005 Company: Mylan Pharmaceuticals, Inc.

March

First Time Generic Approvals

• Octreotide Acetate Injection (Preservative Free) 0.05 mg/mL, 0.1 mg/mL, and 0.5 mg/mL
  Approved: March 28, 2005 Company: Beford Laboratories
  Generic for: Sandostatin
• Miconazole Nitrate Vaginal Cream (3-Day Treatment) (OTC) 4%
  Approved: March 2, 2005 Company: Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Monistat 3 Vaginal Cream
• Griseofulvin Oral Suspension, USP 125 mg/5 mL
  Approved: March 2, 2005 Company: Stiefel Laboratories, Inc.
  Generic for: Grifuvin V
• Dantrolene Sodium Capsules 25 mg, 50 mg, and 100 mg
  Approved: March 1, 2005 Company: Impax Laboratorties, Inc.
  Generic for: Dantrium Capsules

Other Generic Approvals

• Nitrofurantoin (Monohydrate/Macrocrystals) Capsules 100 mg
  Approved: March 30, 2005 Company:Ranbaxy Laboratories Limited
• Cyclosporine Capsules USP (Modified) 25 mg, 50 mg, and 100 mg
  Approved: March 29, 2005 Company: Ivax Pharmaceuticals S.R.O.
• Quinapril Hydrochloride and Hydrochlorothiazide Tablets 10 mg (Base)/12.5 mg, 20 mg (Base)/12.5 mg, and 20 Mg (Base)/25 mg
  Approved: March 28, 2005 Company: Mylan Pharmaceuticals, Inc.
• Mometasone Furoate Ointment, USP 0.1%
  Approved: March 28, 2005 Company: Altana Inc.
• Terbutaline Sulfate Tablets, USP 2.5 mg and 5 mg
  Approved: March 25, 2005 Company: Lannett Holdings, Inc.
• Fluconazole Injection (in 0.9% Sodium Chloride Injection) 2 mg/mL; packaged in 200 mg/100 mL and 400 mg/200 mLl Single-Dose Plastic Containers
  Approved: March 25, 2005 Company: Apotex Corp.
• Fluconazole Injection (in 5% Dextrose Injection) 2 mg/mL; packaged in 200 mg/100 mL and 400 mg/200 mL Single-Dose Plastic Containers
  Approved: March 25, 2005 Company: Apotex Corp.
• Cyclosporine Oral Solution, USP (Modified) 100 mg/mL
  Approved: March 25, 2005 Company: Ivax Pharmaceuticals S.R.O.
• Dicyclomine Hydrochloride Syrup, USP 10 mg/5 mL
  Approved: March 24, 2005 Company: Mikart, Inc.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: March 23, 2005 Company: Ivax Pharmaceuticals, Inc.
• Carboplatin For Injection, USP 50 mg, 150 mg, and 450 mg Single-Dose Vials
  Approved: March 18, 2005 Company: Eon Labs, Inc.
• Famotidine Tablets, USP (OTC) 10 mg
  Approved: March 18, 2005 Company: L. Perrigo Company
• Cilostazol Tablets 50 mg
  Approved: March 11, 2005 Company: Corepharma, LLC
  
• Clarithromycin Tablets, USP 250 mg and 500 mg
  Approved: March 11, 2005 Company: Genpharm Inc.
• Famotidine Tablets, USP (OTC) 10 mg
  Approved: March 7, 2005 Company: Wockhardt Limited
• Buprenorphine Hydrochloride Injection 0.3 mg (Base)/mL
  Approved: March 2, 2005 Company: Bedford Laboratories
• Quinapril Hydrochloride Tablets 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: March 2, 2005 Company: Eon Labs, Inc.
• Ranitidine Injection, USP 25 mg/mL; packaged in 50 mg/2 mL Vials
  Approved: March 2, 2005 Company: Ben Venue Laboratories, Inc.
• Cilostazol Tablets 100 mg
  Approved: March 1, 2005 Company: Ivax Pharmaceuticals, Inc.
• Torsemide Tablets 5 mg, 10 mg, and 20 mg
  Approved: March 1, 2005 Company: Roxane Laboratories, Inc.

February

First Time Generic Approvals

• Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL and 80 mg/mL
  Approved: February 23, 2005 Company: Sicor Pharmaceuticals, Inc.
  Generic for: Depo-Medrol Injectable Suspension

Other Generic Approvals

• Cephalexin Capsules USP 250 mg and 500 mg
  Approved: February 24, 2005 Company: Yung Shin Pharmaceutical Industrial Co.
• Primidone Tablets USP 50 mg and 250 mg
  Approved: February 24, 2005 Company: Vintage Pharmaceuticals, LLC
• Terconazole Vaginal Cream 0.4%
  Approved: February 18, 2005 Company: Altana Inc.
• Methimazole Tablets USP 5 mg, 10 mg, and 20 mg
  Approved: February 18, 2005 Company: Cedar Pharmaceuticals LLC
• Fenoldopam Mesylate Injection USP 10 mg (Base)/mL; packaged 1 mL and 2 mL Single-Dose Ampules
  Approved: February 15, 2005 Company: Sabex 2002 Inc.
• Amoxicillin And Clavulanate Potassium Tablets USP (Chewable 200 mg/28.5 mg (Base) and 400 mg/57 mg (Base)
  Approved: 2/9/2005 Company: Teva Pharmaceuticals USA
• Citalopram Hydrobromide Tablets 10 mg (Base), 20 mg (Base), and 40 mg (Base)
  Approved: February 3, 2005 Company: Mylan Pharmaceuticals, Inc.

January

First Time Generic Approvals

• Fentanyl Transdermal Systems 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour
  Approved: January 28, 2005 Company: Mylan Technologies, Inc.
  Generic for: Duragesic Transdermal Systems
  Treatment for: Chronic Pain
• Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray)
  Approved: January 27, 2005 Company: Apotex Inc.
  Generic for: DDAVP Nasal Spray
  Treatment for: Diabetes Insipidus and Nocturnal Enuresis
• Levofloxacin Tablets 750 mg
  Approved: January 26, 2005 Company: Teva Pharmaceuticals USA
  Generic for: Levaquin Tablets
  Treatment for: Bacterial Infections
• Clarithromycin Extended-Release Tablets 1000 mg
  Approved: January 26, 2005 Company: Ranbaxy Laboratories Limited
  Generic for: Biaxin XL Extended-Release Tablets
  Treatment for: Bacterial Infections
• Estradiol Transdermal System 0.025 mg/day and 0.075 mg/day
  Approved: January 26, 2005 Company: Mylan Technologies, Inc.
  Generic for: Climara
  Treatment for: Menopausal Symptoms
• Terconazole Vaginal Cream 0.4%
  Approved: January 19, 2005 Company: Taro Pharmaceuticals USA, Inc.
  Generic for: Terazole 7 Vaginal Cream
  Treatment for: Vaginal Candidiasis
• Potassium Iodide Oral Solution USP 65 mg/mL
  Approved: January 12, 2005 Company: Fleming & Company, Pharmaceuticals
  Generic for: Thyrosafe Tablets
  Treatment for: Thyroid Protection in a Radiation Emergency

Other Generic Approvals

• Clindamycin Hydrochloride Capsules USP 75 mg (Base), 150 mg (Base), and 300 mg (Base)
  Approved: January 31, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Testosterone Cypionate Injection USP 200 mg/mL; packaged in 1 mL and 10 mL multiple-dose vials
  Approved: January 31, 2005 Company: Paddock Laboratories
• Atenolol Tablets USP 25 mg, 50 mg, and 100 mg
  Approved: January 28, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Quinapril Hydrochloride Tablets 5 mg (Base), 10 mg (Base), 20 mg (Base), and 40 mg (Base)
  Approved: January 28, 2004 Company: Par Pharmaceutical, Inc.
• Sulfamethoxazole and Trimethoprim Tablets USP 400 mg/80 mg and 800 mg/160 mg
  Approved: January 27, 2005 Company: Interpharm, Inc.

December

First Time Generic Approvals


• Ciclopirox Olamine Cream USP 0.77%
  Approved: December 29, 2004 Company: Altana Inc.
  Generic for: Loprox Cream
  Treatment for: Topical Fungal Infections
• Hydrocortisone Butyrate Ointment USP 0.1%
  Approved: December 27, 2004
  Company: Taro Pharmaceutical Industries Ltd.
  Generic for: Locoid Ointment
  Treatment for: Inflammatory Skin Conditions
• Clindamycin Phosphate Vaginal Cream USP 2% (Base)
  Approved: December 27, 2004 Company: Altana Inc.
  Generic for: Cleocin Vaginal Cream
  Treatment for: Vaginal Bacterial Infections
• Glycopyrrolate Tablets USP 1 mg and 2 mg
  Approved: December 22, 2004 Company: Corepharma LLC
  Generic for: Robinul & Robinul Forte
  Treatment for: Peptic Ulcers
• Mometasone Furoate Cream USP 0.1%
  Approved: December 21, 2004
  Company: Taro Pharmaceuticals U.S.A., Inc.
  Generic for: Elocon Cream
  Treatment for: Inflammatory Skin Conditions
• Halobetasol Propionate Cream 0.05%
  Approved: December 16, 2004
  Company: Agis Industries (1983) Ltd., Altana Inc.
  Generic for: Ultravate Cream
  Treatment for: Inflammatory Skin Conditions
• Halobetasol Propionate Ointment 0.05%
  Approved: December 16, 2004
  Company: Agis Industries (1983) Ltd., Altana Inc., Taro Pharmaceuticals USA, Inc.
  Generic for: Ultravate Ointment
  Treatment for: Inflammatory Skin Conditions
• Quinapril Tablets USP 5 mg, 10 mg, 20 mg, and 40 mg
  Approved: December 15, 2004
  Company: Ranbaxy Laboratories Limited
  Generic for: Accupril Tablets
  Treatment for: Hypertension
• Citalopram Hydrobromide Oral Solution 10 mg (Base)/ 5 mL
  Approved: December 13, 2004 Company: Roxane Laboratories, Inc.
  Treatment for: Celexa Oral Solution
  Treatment for: Depression
• Didanosine Delayed-Release Capsules 200 mg, 250 mg, and 400 mg
  Approved: December 3, 2004 Company: Barr Laboratories, Inc.
  Generic for: Videx EC Delayed-Release Capsules
  Treatment for: HIV Infection
• Bupropion Hydrochloride Extended-Release Tablets USP 200 mg
  Approved: December 3, 2004 Company: Impax Laboratories, Inc.
  Generic for: Wellbutrin SR Sustained-Release Tablets
  Treatment for: Depression
• Fosinopril Sodium And Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: December 3, 2004 Company: Andrx Pharmaceuticals,LLC
  Generic for: Monopril HCT Tablets
  Treatment for: Hypertension

November

First Time Generic Approvals


• Cilostazol Tablets
  Approved: November 23, 2004
  Company: Alphapharm, CorePharma, Eon Labs
  Generic for: Pletal - Treatment for: Intermittent Claudication
• Carboplatin Injection 10 mg/mL 60 mL single-dose vials
  Approved: November 23, 2004 Company: Mayne Pharma (USA) Inc.
  Generic for: Paraplatin Injection (Aqueous) - Treatment for: Cancer
• Ranitidine Injection USP 25 mg/mL
  Approved: November 19, 2004 Company: Bedford Laboratories
  Generic for: Zantac Injection - Treatment for: Duodenal Ulcers
• Pilocarpine Hydrochloride Tablets 5 mg
  Approved: November 16, 2004 Company: Corepharma, LLC
  Generic for: Salagen - Treatment for: Dry Mouth
• Felodipine Extended-Release Tablets USP 2.5 mg, 5 mg, and 10 mg
  Aapproved: November 2, 2004 Company: Mutual Pharmaceutical Company, Inc.
  Generic for: Plendil ER Tablets - Treatment for: Hypertension

October

First Time Generic Approvals


• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
  Generic for: Celexa
  Approved: October 28, 2004
  Aurobindo Pharma Limited, Corepharma LLC, Dr. Reddy’s Laboratories Limited, Eon Labs, Inc., Purepac Pharmaceutical Co.
• Gabapentin Tablets 600 mg and 800 mg
  Generic for: Neurontin
  Approved: October 21, 2004
  Purepac Pharmaceutical Co.
• Levofloxacin Tablets 250 mg and 500 mg
  Generic for: Levaquin
  Approved: October 15, 2004
  Mylan Pharmaceuticals, Inc.
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Generic for: Glucophage XR
  Approved: October 14, 2004
  Barr Laboratories, Inc.
• Carboplatin For Injection USP 50 mg, 150 mg, and 450 mg
  Generic for: Paraplatin for Injection
  Approved: October 14, 2004
  American Pharmaceutical Partners, Inc., Bedford Laboratories, Pharmachemie B.V., Mayne Pharma (USA), Inc.
• Flumazenil Injection 0.1 mg/mL
  Generic for: Romazicon Injection
  Approved: October 12, 2004
  Sicor Pharmaceuticals, Inc., Bedford Laboratories, Baxter Healthcare Corporation, Apotex Corp., American Pharmaceutical Partners, Inc.

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All Generic Approvals
• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
  Dr. Reddy’s Laboratories Limited Approved: October 28, 2004
  Corepharma LLC Approved: October 28, 2004
  Eon Labs, Inc. Approved: October 28, 2004
  Purepac Pharmaceutical Co. Approved: October 28, 2004
  Aurobindo Pharma Limited Approved: October 28, 2004
• Lithium Carbonate Extended-Release Tablets USP 300 mg
  Roxane Laboratories, Inc. Approved: October 28, 2004
• Bethanechol Chloride Tablets USP 5 mg, 10 mg, 25 mg and 50 mg
  Amide Pharmaceutical, Inc. Approved: October 28, 2004
• Medroxyprogesterone Acetate Injectable Suspension USP 150 mg/mL; in 1 mL prefilled syringes
  Sicor Pharmaceuticals, Inc. Approved: October 27, 2004
• Enalapril Maleate and Hydrochlorothiazide Tablets USP 5 mg/12.5 mg and 10 mg/25 mg
  Apotex Inc. Approved: October 27, 2004
• Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 mg
  Aurobindo Pharma Limited Approved: October 22, 2004
• Gabapentin Tablets 600 mg and 800 mg
  Purepac Pharmaceutical Co. Approved: October 21, 2004
• Cefuroxime Axetil Tablets USP 250 mg (base) and 500 mg (base)
  Teva Pharmaceuticals, USA Approved: October 18, 2004
• Cefazolin For Injection USP 10 gram/vial; (Pharmacy Bulk Package)
  Hikma Farmaceutica (Portugal), LDA Approved: October 18, 2004
• Levofloxacin Tablets 250 mg and 500 mg
  Mylan Pharmaceuticals, Inc. Approved: October 15, 2004
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Barr Laboratories, Inc. Approved: October 14, 2004
• Carboplatin For Injection USP 50 mg, 150 mg, and 450 mg
  Mayne Pharma (USA), Inc. Approved: October 14, 2004
  American Pharmaceutical Partners, Inc. Approved: October 14, 2004
  Pharmachemie B.V. Approved: October 14, 2004
  Bedford Laboratories Approved: October 14, 2004
• Betamethasone Dipropionate Ointment USP (Augmented) 0.05% (base)
  Taro Pharmaceuticals U.S.A., Inc. Approved: October 12, 2004
• Fenoldopam Mesylate Injection USP 10 mg (base)/mL; packaged in 1 mL and 2 mL single-dose vials
  Bedford Laboratories Approved: October 12, 2004
• Flumazenil Injection 0.1 mg/mL; packaged in 0.5 mg/5 mL and 1 mg/10 mL multiple dose vials
  Apotex Corp. Approved: October 12, 2004
  Baxter Healthcare Corporation Approved: October 12, 2004
  American Pharmaceutical Partners, Inc. Approved: October 12, 2004
  Sicor Pharmaceuticals, Inc. Approved: October 12, 2004
  Bedford Laboratories Approved: October 12, 2004
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Andrx Pharmaceuticals, LLC Approved: October 15, 2004
  Sandoz Inc. Approved: October 8, 2004
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Teva Pharmaceuticals Usa, Inc. Approved: October 8, 2004
• Ciprofloxacin Tablets USP 250 mg, 500 mg, and 750 mg
  Taro Pharmaceutical Industries Ltd. Approved: October 6, 2004
• Ketorolac Tromethamine Injection USP 15 mg/mL; 30 mg/mL, and 60 mg/2 mL single-dose vials
  Sabex 2002 Inc. Approved: October 6, 2004
• Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg
  Apotex Inc. Approved: October 5, 2004
• Loratadine Oral Solution USP (OTC) 5 mg/5 mL
  Apotex Inc. Approved: October 5, 2004
• Prednisolone Sodium Phosphate Oral Solution 15 mg (base)/5 mL
  Morton Grove Pharmaceuticals, Inc. Approved: October 4, 2004
• Ribavirin Capsules 200 mg
  Teva Pharmaceuticals USA Approved: October 4, 2004
• Mefloquine Hydrochloride Tablets 250 mg
  Roxane Laboratories, Inc. Approved: October 1, 2004
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Purepac Pharmaceutical Company Approved: October 1, 2004

September

First Time Generic Approvals
Carnitor (levocarnitine) Tablets, USP 330 mg
Ercatab (ergotamine tartrate and caffeine) Tablets, USP 1 mg/100 mg
Rowasa (mesalamine) Rectal Suspension, USP (Enema) 4 g/60 mL
Sandimmune (cyclosporin) Oral Solution, USP 100 mg/mL
Tri-Norinyl (norethindrone and ethinyl estradiol) Tablets, 28-day regimen
Zinecard (dexrazoxane) for Injection 250 mg and 500 mg; single-dose vials

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All Generic Approvals
• Mesalamine Rectal Suspension USP (Enema) 4 g/60 mL
  Teva Pharmaceuticals USA Approved: September 30, 2004
• Tizanidine Hydrochloride Tablets 2 mg (base) and 4 mg (Base)
  Ivax Pharmaceuticals, Inc. Approved: September 30, 2004
• Clorazepate Dipotassium Tablets USP 3.75 mg, 7.5 mg, and 15 mg
  Ranbaxy Laboratories Limited Approved: September 29, 2004
• Norethindrone and Ethinyl Estradiol Tablets USP 0.5 mg/0.035 mg and 1 mg/0.035 mg (28-Day)(Aranelle Tabs)
  Barr Laboratories, Inc. Approved: September 29, 2004
• Haloperidol Injection USP 5 mg/mL; packaged in 1 mL ampules
  Sabex 2002 Inc. Approved: September 29, 2004
• Dexrazoxane For Injection 250 mg and 500 mg; packaged in single-dose vials
  Bedford Laboratories Approved: September 28, 2004
• Oxycodone Hydrochloride Extended-Release Tablets 80 mg
  Impax Laboratories, Inc. Approved: September 27, 2004
• Warfarin Sodium Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg
  Genpharm Inc. Approved: September 27, 2004
• Bromocriptine Mesylate Tablets USP 2.5 mg (base)
  Mylan Pharmaceuticals, Inc. Approved: September 24, 2004
• Clindamycin Injection USP 150 mg/mL (Pharmacy Bulk Package)
  Bedford Laboratories Approved: September 24, 2004
• Clarithromycin Tablets USP 250 mg and 500 mg
  Ranbaxy Laboratories Limited Approved: September 24, 2004
• Ibuprofen Oral Suspension USP 100 mg/5 mL
  Perrigo R & D Company Approved: September 23, 2004
• Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets 10 mg/240 mg (OTC) (24-Hour Formulation)
  Ranbaxy Laboratories Limited Approved: September 22, 2004
• Milrinone Lactate Injection 1 mg (base)/mL; packaged in 10 mL and 20 mL single-dose vials
  Apotex Corp. Approved: September 21, 2004
• Levocarnitine Tablets USP 330 mg
  Corepharma LLC Approved: September 20, 2004
• Carbamazepine Oral Suspension USP 100 mg/5 mL
  Taro Pharmaceutical Industries, Ltd. Approved: September 20, 2004
• Mesalamine Rectal Suspension USP (Enema) 4 g/60 mL
  Agis Industries (1983), Ltd. Approved: September 17, 2004
• Cyclosporin Oral Solution USP 100 mg/mL
  Morton Grove Pharmaceuticals, Inc. Approved: September 17, 2004
• Ergotamine Tartrate and Caffeine Tablets USP 1 mg/100 mg
  West-Ward Pharmaceutical Corp. Approved: September 17, 2004
• Nicotine Polacrilex Gum USP (OTC) 2 mg and 4 mg (base); Regular, Orange and Mint Flavors
  L. Perrigo Company Approved: September 16, 2004
• Fluticasone Propionate Cream 0.05%
  KV Pharmaceutical Company Approved: September 10, 2004
• Ciprofloxacin Tablets USP 250 mg, 500 mg, and 750 mg
  Unique Pharmaceutical Laboratories Approved: September 10, 2004
• Brimonidine Tartrate Ophthalmic Solution 0.2%
  Ivax Pharmaceuticals, Inc. Approved: September 10, 2004
• Amantadine Hydrochloride Syrup USP 50 mg/5 mL
  Silarx Pharmaceuticals, Inc. Approved: September 10, 2004
• Oxaprozin Tablets USP 600 mg
  Torpharm, Inc. Approved: September 2, 2004

August

First Time Generic Approvals
Loprox (ciclopirox) Topical Suspension, 0.77% (Lotion)
Carnitor (levocarnitine) Oral Solution, USP 1 g/10 mL
Brevibloc (esmolol hydrochloride) Injection 10 mg/mL
Lopressor HCT (metoprolol and hydrochlorothiazide) Tablets
Aloprim (allopurinol sodium) for Injection 500 mg (base)/vial


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All Generic Approvals
• Ofloxacin Ophthalmic Solution USP 0.3%
  Company: Pharmaforce, Inc. Approved: August 31, 2004
• Carbidopa and Levodopa Orally Disintegrating Tablets 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg
  Company: Schwarz Pharma, Inc. Approved: August 27, 2004
• Doxylamine Succinate Tablets USP (OTC) 25 mg
  Company: LNK International, Inc. Approved: August 27, 2004
• Allopurinol Sodium For Injection 500 mg (base)/Vial
  Company: Bedford Laboratories Approved: August 26, 2004
• Dextroamphetamine Sulfate Extended-Release Capsules 5 mg, 10 mg, and 15 mg
  Company: Able Laboratories, Inc. Approved: August 25, 2004
• Haloperidol Injection USP (Preservative-Free) 5 mg (base)/mL; packaged in 5 mg (base)/1 mL syringes, single-use vials, and 50 mg (base)/10 mL multiple-dose vials
  Company: Apotex Corp. Approved: August 25, 2004
• Minoxidil Topical Solution USP (For Men) (OTC) 5%
  Company: Harmony Labs, Inc. Approved: August 24, 2004
• Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg, 100 mg/25 mg, and 100 mg/50 mg
  Company: Mylan Pharmaceuticals, Inc. Approved: August 20, 2004
• Loratadine Oral Solution USP (OTC) 5 mg/5 mL
  Company: Taro Pharmaceutical Industries Ltd. Approved: August 20, 2004
• Loratadine Oral Solution USP (OTC) 5 mg/5 mL
  Company: Morton Grove Pharmaceuticals, Inc. Approved: August 20, 2004
• Loratadine Oral Solution USP (OTC) 5 mg/5 mL
  Company: Ranbaxy Laboratories Limited Approved: August 20, 2004
• Loratadine Oral Solution USP (OTC) 5 mg/5 mL
  Company: L. Perrigo Company Approved: August 20, 2004
• Nitrofurantoin Capsules USP (macrocrystals) 100 mg
  Company: Mylan Pharmaceuticals, Inc. Approved: August 18, 2004
• Milrinone Lactate in 5% Dextrose Injection 20 mg (base)/100 mL single-dose plastic container
  Company: B. Braun Medical, Inc. Approved: August 18, 2004
• Potassium Chloride Extended-Release Tablets USP 20 mEq
  Company: Eurand Inc. Approved: August 18, 2004
• Methylprednisolone Sodium Succinate For Injection USP 1 gram (base)/vial
  Company: American Pharmaceutical Partners, Inc. Approved: August 12, 2004
• Levocarnitine Oral Solution USP 1 g/10 mL
  Company: Lyne Laboratories, Inc. Approved: August 10, 2004
• Esmolol Hydrochloride Injection 10 mg/mL; Packaged In 100 mg/10 mL Single-Dose Vials Company: Bedford Laboratories Approved: August 10, 2004
• Nitroglycerin Transdermal System 0.2 mg/hour and 0.4 mg/hour
  Company: Schwarz Pharma, Inc. Approved: August 10, 2004
• Ciclopirox Topical Suspension USP, 0.77% (Lotion)
  Company: Altana, Inc. Approved: August 6, 2004

July

• First Time Generic for Diflucan Tablets
  Fluconazole Tablets 50 mg, 100 mg, 150 mg and 200 mg
  Sandoz Inc. Approved: July 29, 2004
  Mylan Pharmaceuticals, Inc. Approved: July 29, 2004
  Novopharm Limited Approved: July 29, 2004
  Apotex Inc. Approved: July 29, 2004
• First Time Generic for Diflucan For Oral Suspension
  Fluconazole For Oral Suspension 10 mg/mL (50 mg/5 mL) and 40 mg/mL (200 mg/5 mL)
  Ranbaxy Laboratories Limited Approved: July 29, 2004
  Roxane Laboratories, Inc. Approved: July 29, 2004
• First Time Generic for Diflucan (in 0.9% Sodium Chloride) Injection
  Fluconazole (in 0.9% Sodium Chloride) Injection 2 mg/mL; packaged in 200 mg/100 mL, and 400 mg/200 mL single-dose vials
  Sicor Pharmaceuticals, Inc. Approved: July 29, 2004
  Bedford Laboratories Approved: July 29, 2004
• First Time Generic for Depo-Provera Injectable Suspension
  Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/1 mL single-dose vials
  Sicor Pharmaceuticals, Inc. Approved: July 28, 2004
• First Time Generic for Lotrisone Lotion
  Clotrimazole and Betamethasone Dipropionate Lotion 1%/0.05% (Base)
  Taro Pharmaceuticals U.S.A., Inc. Approved: July 28, 2004
• Bethanechol Chloride Tablets, USP 5 mg, 10 mg, 25 mg, and 50 mg
  Able Laboratories, Inc. Approved: July 27, 2004
• Sotalol Hydrochloride Tablets, USP (AF) 80 mg, 120 mg, and 160 mg
  Teva Pharmaceuticals USA Approved: July 26, 2004
• Nystatin Topical Powder, USP 100,000 units/gram
  Kali Laboratories, Inc. Approved: July 23, 2004
• Hydroxyzine Hydrochloride Tablets, USP 10 mg, 25 mg and 50 mg
  Able Laboratories, Inc. Approved: July 22, 2004
• Metolazone Tablets, USP 10 mg
  Watson Laboratories, Inc. Approved: July 21, 2004
• Ketorolac Tromethamine Injection, USP 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, packaged in single-dose vials
  Amphastar Pharmaceuticals, Inc. Approved: July 21, 2004
• Ketorolac Tromethamine Injection, USP 15 mg/mL, 30 mg/mL, and 60 mg/2 mL; single-dose vials
  Baxter Healthcare Corporation Approved: July 21, 2004
• Terbutaline Sulfate Injection, USP 1 mg/mL; packaged in 1 mL single-dose vials
  Sicor Pharmaceuticals, Inc. Approved: July 20, 2004
• Midazolam Hydrochloride Injection 1 mg (Base)/mL and 5 mg (Base)/mL
  International Medication Systems, Limited Approved: July 16, 2004
• Nystatin Topical Powder, USP 100,000 units/gram
  Tanon Pharmaceuticals LLC Approved: July 15, 2004
• First Time Generic for Levoxyl Tablets
  Levothyroxine Sodium Tablets, USP 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg Are "AB"-Rated To Levoxyl Tablets Of Jones Pharma Inc.
  Mylan Pharmaceuticals, Inc. Approved: July 13, 2004
• First Time Generic for Pipracil For Injection
  Piperacillin For Injection, USP 40 g/vial (Pharmacy Bulk Package)
  Istituto Biochimico Italiano, S.P.A. Approved: July 12, 2004
• First Time Generic for MiraLax Powder For Oral Solution
  Glycolax (Polyethylene Glycol 3350 Powder For Oral Solution)
  Schwarz Pharma, Inc. Approved: July 2, 2004
• First Time Generic for Phenergan Tablets
  Promethazine Hydrochloride Tablets, USP 12.5 mg, 25 mg, and 50 mg
  Able Laboratories, Inc. Approved: July 1, 2004

June

• First Time Generic for Roxicodone
  Oxycodone Hydrochloride Tablets USP 15 mg and 30 mg
  Mallinckrodt, Inc. Approved: June 30, 2004
• Oxycodone Hydrochloride and Acetaminophen Tablets USP 7.5 mg/500 mg and 10 mg/650 mg
  Mallinckrodt, Inc. Approved: June 30, 2004
• Oxycodone and Acetaminophen Tablets USP 7.5 mg/325 mg and 10 mg/325 mg
  Mallinckrodt, Inc. Approved: June 30, 2004
• Lithium Carbonate Capsules USP 150 mg, 300 mg, and 600 mg
  Able Laboratories, Inc. Approved: June 29, 2004
• Propoxyphene Napsylate and Acetaminophen Tablets USP 100 mg/500 mg
  Vintage Pharmaceuticals, Inc. Approved: June 28, 2004
• First Time Generic for AccuNeb
  Albuterol Sulfate Inhalation Solution 0.042% (Base)
  Nephron Pharmaceuticals Corporation Approved: June 28, 2004
• Loratadine Tablets USP (OTC) 10 mg
  L. Perrigo Company Approved: June 25, 2004
• Carbidopa and Levodopa Extended-Release Tablets 50 mg/200 mg
  Kv Pharmaceutical Company Approved: June 24, 2004
• First Time Generic for Biaxin XL
  Clarithromycin Extended-Release Tablets 500 mg
  Andrx Pharmaceuticals, LLC Approved: June 24, 2004
• First Time Generic for Synthroid
  Levothyroxine Sodium Tablets USP 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg
  Mylan Pharmaceuticals, Inc. Approved: June 23, 2004
• Econazole Nitrate Cream 1%
  Clay-Park Labs, Inc. Approved: June 23, 2004
• Ammonium Lactate Lotion 12% (Base)
  Clay-Park Labs, Inc. Approved: June 23, 2004
• Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/300 mg
  Mikart Inc. Approved: June 23, 2004
• Dimenhydrinate Injection USP 50 mg/mL; packaged In 1 mL and 10 mL Multiple-Dose Vials
  American Pharmaceutical Partners, Inc. Approved: June 23, 2004
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Ranbaxy Laboratories Limited Approved: June 18, 2004
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Teva Pharmaceuticals USA Approved: June 18, 2004
• Ibuprofen Tablets (OTC) 100 mg
  LNK International, Inc. Approved: June 17, 2004
• Carbidopa And Levodopa Extended-Release Tablets 25 mg/100 mg and 50 mg/200 mg
  Torpharm Inc. Approved: June 16, 2004
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Andrx Pharmaceuticals Approved: June 10, 2004
• Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules
  50 mg/325 mg/40 mg/30 mg
  Anabolic Laboratories Approved: June 10, 2004
• Doxazosin Mesylate Tablets 1 mg, 2 mg, 4 mg and 8 mg
  Clonmel Healthcare Approved: June 10, 2004
• First Time Generic for Ciloxan
  Ciprofloxacin Ophthalmic Solution 0.3%
  Bausch and Lomb Approved: June 9, 2004
• Ciprofloxacin Ophthalmic Solution 0.3%
  Novex Pharma Approved: June 9, 2004
• First Time Generic for Cipro
  
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Eon Labs, Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Teva Pharmaceuticals USA Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Carlsbad Technology, Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Genpharm Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Barr Laboratories, Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Cobalt Pharmaceuticals Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Dr. Reddy’s Laboratories, Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Hikma Pharmaceuticals Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  IVAX Pharmaceuticals, Inc. Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Martec Scientific Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Mylan Pharmaceuticals Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Ranbaxy Pharmaceuticals Approved: June 9, 2004
• Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg
  Sandoz Scientific Approved: June 9, 2004

May

• Ammonium Lactate Lotion 12% (Base)
  Taro Pharmaceuticals USA, Inc. Approved: May 28, 2004
• First Time Generic for Sporanox
  Itraconazole Capsules 100 mg
  Eon Labs, Inc. Approved: May 28, 2004
• Prochlorperazine Edisylate Injection USP 5 mg (base)/mL; packaged in 10 mg (base)/2 mL single-dose vials and 50 mg (base)/10 mL multiple-dose vials
  Bedford Laboratories Approved: May 28, 2004
• First Time Generic for Metrocream
  Metronidazole Topical Cream 0.75%
  Altana Inc. Approved: May 28, 2004
• Midodrine Hydrochloride Tablets 2.5 mg and 5 mg
  Impax Laboratories, Inc. Approved: May 27, 2004
• First Time Generic for Zyban SR
  Bupropion Hydrochloride Extended-Release Tablets 150 mg
  Impax Laboratories, Inc. Approved: May 27, 2004
• Terbutaline Sulfate Injection USP 1 mg/mL, packaged in 1 mL single-dose vials
  American Pharmaceutical Partners, Inc. Approved: May 26, 2004
• Amoxicillin & Clavulanate Potassium For Oral Suspension USP 200 mg/28.5 mg (base)/5 mL and 400 mg/57 mg (base)/5 mL
  Teva Pharmaceuticals USA Approved: May 25, 2004
• Prednisolone Sodium Phosphate Oral Solution 5 mg (Base)/ 5 mL
  Paddock Laboratories, Inc. Approved: May 25, 2004
• First Time Generic for Biaxin
  Clarithromycin Tablets USP 250 mg and 500 mg
  Roxane Laboratories, Inc. Approved: May 25, 2004
• Diltiazem Hydrochloride Extended-Release Capsules USP 120 mg, 180 mg, 240 mg, 300 mg (Once-A-Day Dosage)
  Torpharm Inc. Approved: May 20, 2004
• Morphine Sulfate Extended-Release Tablets 15 mg
  KV Pharmaceutical Company approved: May 19, 2004
• Morphine Sulfate Extended-Release Tablets 60 mg
  KV Pharmaceutical Company Approved: May 19, 2004
• First Time Generic for Ocuflox
  Ofloxacin Ophthalmic Solution USP 0.3%
  Novex Pharma Approved: May 14, 2004
• Ofloxacin Ophthalmic Solution USP 0.3%
  Alcon Inc. Approved: May 14, 2004
• Ofloxacin Ophthalmic Solution USP 0.3%
  Bausch & Lomb, Inc. Approved: May 14, 2004
• Ofloxacin Ophthalmic Solution USP 0.3%
  Hi-Tech Pharmacal Co., Inc. Approved: May 14, 2004
• First Time Generic for Cutivate
  Fluticasone Propionate Cream 0.05%
  Atrix Laboratories, Inc. Approved: May 14, 2004
• Fluticasone Propionate Cream 0.05%
  Clay-Park Labs, Inc. Approved: May 14, 2004
• Fluticasone Propionate Ointment 0.005%
  Clay-Park Labs, Inc. May 14, 2004
• Fluticasone Propionate Cream 0.05%
  Altana Inc. Approved: May 14, 2004
• Fluticasone Propionate Ointment 0.005%
  Altana Inc. Approved: May 14, 2004
• Fluoxetine Oral Solution USP 20 mg (base)/5 mL
  Par Pharmaceutical, Inc. Approved: May 14, 2004
• Carbidopa-Levodopa Extended-Release Tablets 25 mg/100 mg & 50 mg/200 mg
  Impax Laboratories, Inc. Approved: May 14, 2004
• First Time Generic for Darvocet N 100
  Propoxyphene Napsylate and Acetaminophen Tablets USP 100 mg/325 mg
  Vintage Pharmaceuticals, Inc. Approved: May 7, 2004

April

• Theophylline Extended-Release Tablets 300mg and 450 mg
  Able Laboratories, Inc. Approved: April 30, 2004
• Metolazone Tablets, USP 10 mg
  Roxane Laboratories, Inc. Approved: April 29, 2004
• Ketoconazole Cream 2%
  Altana Inc. Approved: April 28, 2004
• First Time Generic for Fludara for Injection
  Fludarabine Phosphate Injection 25 mg/mL; packaged in 50 mg/2 mL Single-Dose Vials
  Sicor Pharmaceuticals, Inc. Approved: April 28, 2004
• First Time Generic for Neurontin 100 mg
  Gabapentin Tablets 100 mg, 300 mg, and 400 mg
  Ivax Pharmaceuticals, Inc. Approved: April 28, 2004
• First Time Generic for Uniphyl
  Theophylline Extended-Release Tablets 400 mg and 600 mg
  Able Laboratories, Inc. Approved: April 27, 2004
• Methadone Hydrochloride Tablets, USP 5 mg and 10 mg
  Mallinckrodt Inc. Approved: April 27, 2004
• First Time Generic for Brethine Injection
  Terbutaline Sulfate Injection, UAP 1 mg/mL
  Bedford Laboratories Approved: April 23, 2004
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Eon Labs, Inc. Approved: April 23, 2004
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Ranbaxy Laboratories Limited Approved: April 23, 2004
• Propafenone Hydrochloride Tablets 150 mg, 225 mg, and 300 mg
  Pliva, Inc. Approved: April 23, 2004
• First Time Generic for Remeron
  Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 mg
  Caraco Pharmaceutical Laboratories, Ltd. Approved: April 22, 2004
• First Time Generic for Ovcon-35
  Norethindrone and Ethinyl Estradiol Tablets, USP 0.4 mg/0.035 mg; 21-Day Cycle (Balziva-21 Tablets)
  Barr Laboratories, Inc. Approved: April 22, 2004
• First Time Generic for Ovcon-35
  Norethindrone and Ethinyl Estradiol Tablets, USP 0.4 mg/0.035 mg; 28-Day Cycle (Balziva-28 Tablets)
  Barr Laboratories, Inc. Approved: April 22, 2004
• Cladribine Injection 1 mg/mL; packaged in 10 mL Single-Dose Vials
  American Pharmaceutical Partners, Inc. Approved: April 22, 2004
• Diazepam Injection, USP 5 mg/mL packaged in 5 mg/1 mL and 10 mg/2 mL Single-Dose Vials & 50 mg/mL Multiple-Dose Vials
  Parenta Pharmaceuticals, Inc. Approved: April 15, 2004
• Sotalol Hydrochloride Tablets 80 mg, 120 mg, and 160 mg
  Mutual Pharmaceutical Company, Inc. Approved: April 8, 2004
• First Time Generic for Rebetol
  Ribavirin Capsules 200 mg
  Sandoz, Inc. Approved: April 6, 2004
• First Time Generic for Rebetol
  Ribavirin Capsules 200 mg
  Three Rivers Pharmaceuticals, LLC Approved: April 6, 2004
• First Time Generic for Terazol 3
  Terconazole Vaginal Cream 0.8%
  Taro Pharmaceuticals U.S.A., Inc. Approved: April 6, 2004

March

• Clindamycin Phosphate Topical Solution USP, 1% (base)
  Taro Pharmaceutical Industries Ltd. Approved: March 31, 2004

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