Generic Drug Approvals for 2006
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
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
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.
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
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.
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.
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.
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
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.
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
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.
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