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.

Generic Approvals Archive