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