Generic Drug Approvals for 2004

March

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

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

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

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

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

• 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

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

• 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

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.

• 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

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

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

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