Generic Drug Approvals: November 2006
First Time Generic Approvals
- Cefazolin for
Injection USP, (Pharmacy Bulk Package) 100 grams (base)/vial
and 300 grams (base)/vial
Approved: November 29, 2006 Samson Medical Technologies, L.L.C.
Generic for: Kefzol for Injection - Ondansetron
Injection USP, 2 mg/mL; 2 mL single-dose vials and 20 mL
multiple-dose vials
Approved: November 22, 2006 Teva Pharmaceuticals USA
Generic for: Zofran Injection - Ondansetron and
Dextrose Injection, 0.64 mg/mL, 50 mL Flexible Plastic
Containers
Approved: November 22, 2006 Sicor Pharmaceuticals, Inc.
Generic for: Zofran Injection Premixed In Dextrose - Pravastatin Sodium
Tablets 10 mg, 20 mg, 30 mg, and 40 mg
Approved: November 21, 2006 Pliva Hrvatska d.o.o.
Generic for: Pravachol Tablets - Sulfacetamide
Sodium Topical Suspension USP, 10%
Approved: November 17, 2006 Altana Inc.
Generic for: Klaron Lotion - Oxybutynin Chloride
Extended-Release Tablets 5 mg and 10 mg
Approved: November 9, 2006 Mylan Pharmaceuticals Inc.
Generic for: Ditropan XL Extended-Release Tablets - Oxybutynin Chloride
Extended-Release Tablets 15 mg
Approved: November 9, 2006 Impax Laboratories, Inc.
Generic for: Ditropan XL Extended-Release Tablets
Other Generic Approvals
- Moexipril Hydrochloride
Tablets, 7.5 mg and 15 mg
Approved: November 30, 2006 Paddock Laboratories, Inc. - Citalopram Hydrobromide
Tablets 10 mg (base), 20 mg (base) and 40 mg (base)
Approved: November 30, 2006 Interpharm Inc. - Paclitaxel Injection
USP, 6 mg/mL; 5 mL, 16.7 mL, and 50 mL vials
Approved: November 27, 2006 Dabur Oncology plc - Doxycycline
Tablets, 50 mg, 75 mg, and 100 mg
Approved: November 27, 2006 Sandoz Inc. - Ampicillin
and Sulbactam for Injection USP, 10 grams (base)/5 grams (base)
15 g Pharmacy Bulk Package
Approved: November 27, 2006 Instituto Biochimico Italiano, S.P.A. - Sulfamethoxazole
and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5
mL
Approved: November 13, 2006 Teva Pharmaceuticals USA -
Thallous Chloride Tl-201 Injection USP, 2 mCi/mL
Approved: November 9, 2006 TCI Medical, Inc. - Promethazine
Hydrochloride Injection USP, 25 mg/mL and 50 mg/mL; 1 mL
ampules
Approved: Approved: November 8, 2006 Sandoz Canada, Inc. - Meloxicam Tablets,
7.5 mg and 15 mg
Approved: November 7, 2006 Taro Pharmaceutical Industries, Ltd. - Doxycycline Tablets
50 mg, 75 mg, and 100 mg
Approved: November 7, 2006 Mylan Pharmaceuticals, Inc. - Hydrocodone
Bitartrate and Ibuprofen Tablets 5 mg/200 mg, 7.5 mg/200 mg and
10 mg/200 mg
Approved: November 6, 2006 Vintage Pharmaceuticals, LLC - Bethanechol Chloride
Tablets USP, 5 mg, 10 mg, 25 mg and 50 mg
Approved: November 1, 2006 Impax Laboratories, Inc.
