Generic Drug Approvals: October 2005
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.
