Generic Drug Approvals: November 2005
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.
