Generic Drug Approvals for 2005

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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

Generic approvals archive

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