Generic Drug Approvals: April 2006
First Time Generic Approvals
- Pravastatin Sodium
Tablets 10 mg, 20 mg, and 40 mg
Approved: April 24, 2006 Teva Pharmaceuticals USA
Generic for: Pravachol Tablets - Oxycodone
and Acetaminophen Tablets USP, 10 mg/650 mg
Approved: April 19, 2006 Mikart Inc.
Generic for: Percocet Tablets 10 mg/650 mg - Benzphetamine HCl
Tablets 50 mg
Approved: April 17, 2006 Paddock Laboratories Inc.
Generic for: Didrex Tablets - Mitoxantrone
Injection USP, (Concentrate) 2 mg/mL; Packaged in 20 mg/10 mL,
25 mg/12.5 mL, and 30 mg/15 mL Multiple-Dose Vials
Approved: April 11, 2006 Bedford Laboratories, Mayne Pharma (USA) Inc., Sicor Pharmaceuticals, Inc., American Pharmaceutical Partners, Inc.
Generic for: Novantrone Injection
Other Generic Approvals
- Oxycodone
and Acetaminophen Tablets USP, 5 mg/400 mg, 7.5 mg/400 mg, 10
mg/400 mg
Approved: April 27, 2006 Mikart Inc. - Promethazine
Hydrochloride Syrup USP, 6.25 mg/5 mL
Approved: April 26, 2006 Vintage Pharmaceuticals, LLC - Isradipine Capsules
USP, 2.5 mg and 5 mg
Approved: April 24, 2006 Amide Pharmaceutical, Inc. - Theophylline
Extended-Release Tablets 400 mg and 600 mg
Approved: April 21, 2006 Nostrum Pharmaceuticals, Inc. - Dipyridamole
Tablets USP, 25 mg, 50 mg, and 75 mg
Approved: April 21, 2006 Amide Pharmaceutical, Inc. - Zonisamide Capsules
25 mg, 50 mg, and 100 mg
Approved: April 20, 2006 Watson Laboratories, Inc. - Cilostazol Tablets
50 mg and 100 mg
Approved: April 20, 2006 Mylan Pharmaceuticals, Inc. - Cyclobenzaprine
Hydrochloride Tablets USP, 5 mg and 10 mg
Approved: April 19, 2006 Jubilant Pharmaceuticals, Inc. - Lovastatin Tablets
USP, 10 mg, 20 mg, and 40 mg
Approved: April 14, 2006 Mutual Pharmaceutical Company, Inc. - Fexofenadine
Hydrochloride Tablets 30 mg, 60 mg and 180 mg
Approved: April 11, 2006 Dr Reddy’s Laboratories Inc. - Hydrocortisone
Sodium Succinate For Injection USP, 100 mg (Base)/2 mL
Single-Dose Vial
Approved: April 6, 2006 Hospira Inc. - Albuterol
Sulfate Inhalation Solution 0.083% (Base); Packaged in 2.5 mg
(Base)/3 mL Unit-Dose Vials
Approved: April 4, 2006 RxElite
