Generic Drug Approvals Archive
Generic Drug Approvals: December 2005
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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