Generic Drug Approvals: March 2005
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.
