Generic Drug Approvals: September 2004
First Time Generic Approvals
Carnitor (levocarnitine) Tablets, USP 330 mg
Ercatab (ergotamine tartrate and caffeine) Tablets, USP 1
mg/100 mg
Rowasa (mesalamine) Rectal Suspension, USP (Enema) 4 g/60
mL
Sandimmune (cyclosporin) Oral Solution, USP 100 mg/mL
Tri-Norinyl (norethindrone and ethinyl estradiol) Tablets,
28-day regimen
Zinecard (dexrazoxane) for Injection 250 mg and 500 mg;
single-dose vials
All Generic Approvals
-
Mesalamine Rectal Suspension USP (Enema) 4 g/60 mL
Teva Pharmaceuticals USA Approved: September 30, 2004 -
Tizanidine Hydrochloride Tablets 2 mg (base) and 4 mg
(Base)
Ivax Pharmaceuticals, Inc. Approved: September 30, 2004 -
Clorazepate Dipotassium Tablets USP 3.75 mg, 7.5 mg, and 15
mg
Ranbaxy Laboratories Limited Approved: September 29, 2004 -
Norethindrone and Ethinyl Estradiol Tablets USP 0.5 mg/0.035 mg
and 1 mg/0.035 mg (28-Day)(Aranelle Tabs)
Barr Laboratories, Inc. Approved: September 29, 2004 -
Haloperidol Injection USP 5 mg/mL; packaged in 1 mL ampules
Sabex 2002 Inc. Approved: September 29, 2004 -
Dexrazoxane For Injection 250 mg and 500 mg; packaged in
single-dose vials
Bedford Laboratories Approved: September 28, 2004 -
Oxycodone Hydrochloride Extended-Release Tablets 80 mg
Impax Laboratories, Inc. Approved: September 27, 2004 - Warfarin Sodium
Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg,
and 10 mg
Genpharm Inc. Approved: September 27, 2004 -
Bromocriptine Mesylate Tablets USP 2.5 mg (base)
Mylan Pharmaceuticals, Inc. Approved: September 24, 2004 -
Clindamycin Injection USP 150 mg/mL (Pharmacy Bulk Package)
Bedford Laboratories Approved: September 24, 2004 -
Clarithromycin Tablets USP 250 mg and 500 mg
Ranbaxy Laboratories Limited Approved: September 24, 2004 -
Ibuprofen Oral Suspension USP 100 mg/5 mL
Perrigo R & D Company Approved: September 23, 2004 -
Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets
10 mg/240 mg (OTC) (24-Hour Formulation)
Ranbaxy Laboratories Limited Approved: September 22, 2004 -
Milrinone Lactate Injection 1 mg (base)/mL; packaged in 10 mL
and 20 mL single-dose vials
Apotex Corp. Approved: September 21, 2004 -
Levocarnitine Tablets USP 330 mg
Corepharma LLC Approved: September 20, 2004 -
Carbamazepine Oral Suspension USP 100 mg/5 mL
Taro Pharmaceutical Industries, Ltd. Approved: September 20, 2004 -
Mesalamine Rectal Suspension USP (Enema) 4 g/60 mL
Agis Industries (1983), Ltd. Approved: September 17, 2004 -
Cyclosporin Oral Solution USP 100 mg/mL
Morton Grove Pharmaceuticals, Inc. Approved: September 17, 2004 -
Ergotamine Tartrate and Caffeine Tablets USP 1 mg/100 mg
West-Ward Pharmaceutical Corp. Approved: September 17, 2004 -
Nicotine Polacrilex Gum USP (OTC) 2 mg and 4 mg (base);
Regular, Orange and Mint Flavors
L. Perrigo Company Approved: September 16, 2004 -
Fluticasone Propionate Cream 0.05%
KV Pharmaceutical Company Approved: September 10, 2004 -
Ciprofloxacin Tablets USP 250 mg, 500 mg, and 750 mg
Unique Pharmaceutical Laboratories Approved: September 10, 2004 -
Brimonidine Tartrate Ophthalmic Solution 0.2%
Ivax Pharmaceuticals, Inc. Approved: September 10, 2004 -
Amantadine Hydrochloride Syrup USP 50 mg/5 mL
Silarx Pharmaceuticals, Inc. Approved: September 10, 2004 -
Oxaprozin Tablets USP 600 mg
Torpharm, Inc. Approved: September 2, 2004
