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
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