Generic Drug Approvals: August 2005
First Time Generic Approvals
- Fexofenadine
Hydrochloride Tablets 30 mg, 60 mg, and 180 mg
Approved: August 31, 2005 Barr Laboratories, Inc.
Generic for: Allegra Tablets - Ceftriaxone
Injection USP, 1 gram/50 mL and 2 grams/50 mL
Approved: August 23, 2005 Baxter Healthcare Corporation
Generic for: Rocephin Injection - Liothyronine Sodium
Injection 10 mcg(base)/mL; 1 mL vials
Approved: August 17, 2005 Pharmaforce, Inc.
Generic for: Triostat Injection - Clonazepam Orally
Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2
mg
Approved: August 3, 2005 Kali Laboratories, Inc.
Generic for: Klonopin Rapidly Disintegrating Tablets
Other Generic Approvals
- Mirtazapine Orally
Disintegrating Tablets 15 mg, 30 mg, and 45 mg
Approved: August 31, 2005 Amide Pharmaceutical, Inc. - Baclofen Tablets USP
10 mg and 20 mg
Approved: August 30, 2005 Vintage Pharmaceuticals, LLC - Cholestyramine for
Oral Suspension USP, 4 g Resin/ 9 g Scoopful or Packet
Approved: August 26, 2005 Par Pharmaceutical, Inc. - Cholestyramine for
Oral Suspension USP, (Light) 4 g Resin/Scoopful or Packet
Approved: August 26, 2005 Par Pharmaceutical, Inc. - Clarithromycin
Extended-Release Tablets 500 mg
Approved: August 25, 2005 Sandoz Inc. - Clarithromycin
Tablets USP, 500 mg
Approved: August 25, 2005 Sandoz Inc. - Prednisolone Syrup
USP, 5 mg/5 mL and 15 mg/5 mL
Approved: August 25, 2005 Apotex Inc. - Fluconazole
Injection (in 0.9% Sodium Chloride), 2 mg/mL; 100 mL
vials
Approved: August 23, 2005 Hikma Farmaceutica (Portugal), LDA -
Amoxicillin and Clavulanate Potassium Tablets USP, 250 mg/125
mg (Base)
Approved: August 23, 2005 Sandoz Inc. - Phenytoin Oral
Suspension USP, 125 mg/5 mL
Approved: August 18, 2005 Vistapharm, Inc. - Citalopram Hydrobromide
Tablets 10 mg, 20 mg and 40 mg (base)
Approved: August 17, 2005 Sandoz Inc. - Cephalexin for Oral
Suspension USP, 125 mg/5 mL and 250 mg/5 mL
Approved: August 17, 2005 Lupin Limited - Fosinopril
Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20
mg/12.5 mg
Approved: August 16, 2005 Watson Laboratories, Inc. - Paroxetine Tablets
USP 10 mg, 20 mg, 30 mg, and 40 mg
Approved: August 15, 2005 Teva Pharmaceuticals USA - Cefazolin for
Injection 1 g/vial and 10 gram/vial (Pharmacy Bulk
Package)
Approved: August 12, 2005 Orchid Healthcare - Clindamycin
Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg
(base)
Approved: August 12, 2005 Lannett Holdings, Inc. - Methotrexate for
Injection USP (Preservative-Free), 1 gram/vial
Approved: August 12, 2005 Bedford Laboratories - Clonazepam Orally
Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2
mg
Approved: August 10, 2005 Barr Laboratories, Inc. - Ciclopirox
Topical Suspension USP (Lotion), 0.77%
Approved: August 10, 2005 Taro Pharmaceuticals USA, Inc. - Clobetasol
Propionate Topical Solution USP, 0.05%
Approved: August 5, 2005 QLT USA, Inc. - Halobetasol
Proprionate Cream 0.05%
Approved: August 4, 2005 Taro Pharmaceuticals USA Inc. - Loxapine Capsules USP,
5 mg, 10 mg, 25 mg and 50 mg (base)
Approved: August 4, 2005 Amide Pharmaceutical, Inc. - Hydrocortisone
Butyrate Cream USP, 0.1%
Approved: August 3, 2005 Taro Pharmaceutical Industries Ltd. - Ceftriaxone for
Injection USP, 250 mg/vial, 500 mg/vial, 1 g/vial, 2 g/vial and
10 g/vial Pharmacy Bulk Package
Approved: August 2, 2005 Orchid Healthcare
