Generic Drug Approvals: June 2005
First Time Generic Approvals
- Carbidopa
and Levodopa Tablets For Oral Suspension 10 mg/100 mg, 25
mg/100 mg, and 25 mg/250 mg
Approved: June 6, 2005 Company: Ranbaxy Laboratories Limited
Generic for: Sinemet Tablets
Other Generic Approvals
- Citalopram Hydrobromide
Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
Approved: June 30, 2005 Company: Cobalt Pharmaceuticals, Inc. - Gabapentin Capsules
100 mg, 300 mg, and 400 mg
Approved: June 30, 2005 Comapny: Mutual Pharmaceutical Company, Inc. - Metformin Hydrochloride
Extended-Release Tablets 750 mg
Approved: June 29, 2005 Company: Ranbaxy Laboratories Limited - Propoxyphene
Napsylate and Acetaminophen Tablets USP, 100 mg/500 mg
Approved: June 28, 2005 Company: Andrx Pharmaceuticals, LLC - Mirtazapine Orally
Disintegrating Tablets 15 mg, 30 mg, and 45 mg
Approved: June 28, 2005 Company: Teva Pharmaceuticals USA - Glyburide
and Metformin Hydrochloride Tablets 1.25 mg/250 mg, 2.5 mg/500
mg, and 5 mg/500 mg
Approved: June 28, 2005 Company: Purepac Pharmaceutical Co. - Cephalexin Capsules
USP, 250 mg and 500 mg
Approved: June 28, 2005 Company: Orchid Healthcare - Nystatin Oral
Suspension USP, 100,000 Units/mL
Approved: June 28, 2005 Company: Vintage Pharmaceuticals, LLC - Haloperidol Decanoate
Injection 50 mg (base)/mL and 100 mg (base)/mL
Approved: June 24, 2005 Company: Sabex 2002 Inc. - Ibuprofen Tablets
USP, (OTC), 200 mg Orange-Coated, Round & Capsule-Shaped
Approved: June 21, 2005 Company: Perrigo R&D Company - Cromolyn
Sodium Inhalation Solution USP, 10 mg/mL; packaged in 20 mg/2
mL Single- Dose Ampules
Approved: June 17, 2005 Company: Breath Limited - Levothyroxine Sodium
Tablets USP, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg,
0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg
Approved: June 16, 2005 Company: Genpharm Inc. -
Clotrimazole & Betamethasone Dipropionate Lotion USP,
1%/0.05%(base)
Approved: June 16, 2005 Company: Altana Inc. - Ciprofloxacin
Tablets USP, 100 mg, 250 mg, 500 mg, and 750 mg
Approved: June 15, 2005 Company: Pliva, Inc. - Fluticasone
Propionate Ointment 0.005%
Approved: June 14, 2005 Company: Taro Pharmaceutical Industries, Ltd. - Halobetasol
Propionate Ointment 0.05%
Approved: June 14, 2005 Company: Alpharma USPD Inc. - Carboplatin
Injection 10 mg/mL; packaged in 50 mg/5 mL, 150 mg/15 mL, and
450 mg/45 mL Multiple-Dose Vials
Approved: June 14, 2005 Company: Spectrum Pharmaceuticals, Inc. - Folic Acid Tablets
USP, 1 mg
Approved: June 14, 2005 Company: Trigen Laboratories, Inc. - Acyclovir Oral
Suspension USP, 200 mg/5 mL
Approved: June 7, 2005 Company: Hi-Tech Pharmacal Co., Inc. - Carisoprodol
Tablets USP, 350 mg
Approved: June 7, 2005 Company: Neil Laboratories, Inc. - Prednisone Tablets
USP, 1 mg
Approved: June 6, 2005 Company: Trigen Laboratories, Inc. - Vinorelbine Tartrate
Injection, 10 mg (base)/mL; packaged in 10 mg (base)/1 mL and
50 mg (base)/5 mL Single-Use Vials
Approved: June 2, 2005 Company: Mayne Pharma (USA), Inc. - Bethanechol Chloride
Tablets USP, 5 mg, 10 mg, 25 mg and 50 mg
Approved: June 1, 2005 Company: Upsher-Smith Laboratories, Inc.
