Generic Drug Approvals: June 2006
First Time Generic Approvals
- Sertraline Hydrochloride
Oral Concentrate 20 mg (base)/mL
Approved: June 30, 2006 Roxane Laboratories, Inc.
Generic for: Zoloft Oral Concentrate - Sertraline Hydrochloride
Tablets 25 mg (base), 50 mg (base), and 100 mg (base)
Approved: June 30, 2006 IVAX Pharmaceuticals, Inc.
Generic for: Zoloft Tablets - Tranylcypromine
Sulfate Tablets 10 mg (base)
Approved: June 29, 2006 Kali Laboratories, Inc.
Generic for: Parnate Tablets, 10 mg - Loratadine Oral
Solution USP, (OTC) 5 mg/5 mL
Approved: June 29, 2006 Silarx Pharmaceuticals, Inc.
Generic for: Claritin Hives Relief Syrup - Simvastatin Tablets
USP 5 mg, 10 mg, 20 mg and 40 mg
Approved: June 23, 2006 IVAX Pharmaceuticals, Inc.
Generic for: Zocor Tablets - Simvastatin Tablets
USP 80 mg
Approved: June 23, 2006 Ranbaxy Inc.
Generic for: Zocor Tablets - Lamotrigine Tablets
(Chewable) 5 mg and 25 mg
Approved: June 21, 2006 Teva Pharmaceuticals USA
Generic for: Lamictal Tablets (Chewable, Dispersible) - Finasteride Tablets
USP, 5 mg
Approved: June 19, 2006 IVAX Pharmaceuticals, Inc.
Generic for: Proscar Tablets - Potassium Citrate
Extended-Release Tablets USP, 5 mEq and 10 mEq
Approved: June 8, 2006 Corepharma, LLC
Generic for: Urocit-K - Metronidazole
Topical Gel 0.75%
Approved: June 6, 2006 Altana Inc.
Generic for: Metrogel Topical Gel
Other Generic Approvals
- Alprazolam Extended-Release
Tablets 0.5 mg, 1 mg, 2 mg, and 3 mg
Approved: June 30, 2006 Sandoz Inc. - Fluticasone
Propionate Cream 0.05%
Approved: June 30, 2006 G & W Laboratories, Inc. - Cefprozil for Oral
Suspension USP 125 mg/5 mL and 250 mg/5 mL
Approved: June 30, 2006 Ranbaxy Laboratories Limited - Ceftriaxone for
Injection USP 1 g/100 mL and 2 g/100 mL
Approved: June 29, 2006 Teva Pharmaceuticals USA - Clonazepam Tablets USP
0.5 mg, 1 mg, and 2 mg
Approved: June 28, 2006 Vintage Pharmaceuticals, LLC - Cyproheptadine
Hydrochloride Syrup USP, 2 mg/5 mL
Approved: June 28, 2006 Lyne Laboratories - Anagrelide Hydrochloride
Capsules 0.5 mg (base) and 1 mg (base)
Approved: June 27, 2006 Alphapharm Pty, Ltd. - Nortriptyline
Hydrochloride Oral Solution USP, 10 mg (base)/5 mL
Approved: June 20, 2006 Taro Pharmaceutical Industries, Ltd. - Quinapril Tablets
USP, 5 mg, 10 mg, 20 mg, and 40 mg
Approved: June 20, 2006 Lupin Limited - Mometasone
Furoate Ointment USP, 0.1%
Approved: June 20, 2006 G & W Laboratories, Inc. - Amoxicillin for Oral
Suspension USP, 200 mg/5 mL and 400 mg/5 mL
Approved: June 19, 2006 Hikma Pharmaceuticals - Amoxicillin for Oral
Suspension USP, 125 mg/5 mL and 250 mg/5 mL
Approved: June 19, 2006 Hikma Pharmaceuticals - Citalopram Hydrobromide
Oral Solution 10 mg (base)/5 mL
Approved: June 14, 2006 Silarx Pharmaceuticals, Inc. - Testosterone Enanthate
Injection USP, 200 mg/mL; 5 mL Multiple-Dose Vials
Approved: June 14, 2006 Paddock Laboratories, Inc. - Triamcinolone
Acetonide Cream USP, 0.025% and 0.1%
Approved: June 9, 2006 Vintage Pharmaceuticals, LLC - Metformin Hydrochloride
Tablets USP 500 mg, 850 mg, and 1000 mg
Approved: June 5, 2006 Interpharm, Inc.
