Generic Drug Approvals: August 2004

First Time Generic Approvals
Loprox (ciclopirox) Topical Suspension, 0.77% (Lotion)
Carnitor (levocarnitine) Oral Solution, USP 1 g/10 mL
Brevibloc (esmolol hydrochloride) Injection 10 mg/mL
Lopressor HCT (metoprolol and hydrochlorothiazide) Tablets
Aloprim (allopurinol sodium) for Injection 500 mg (base)/vial


All Generic Approvals
  • Ofloxacin Ophthalmic Solution USP 0.3%
    Company: Pharmaforce, Inc. Approved: August 31, 2004
  • Carbidopa and Levodopa Orally Disintegrating Tablets 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg
    Company: Schwarz Pharma, Inc. Approved: August 27, 2004
  • Doxylamine Succinate Tablets USP (OTC) 25 mg
    Company: LNK International, Inc. Approved: August 27, 2004
  • Allopurinol Sodium For Injection 500 mg (base)/Vial
    Company: Bedford Laboratories Approved: August 26, 2004
  • Dextroamphetamine Sulfate Extended-Release Capsules 5 mg, 10 mg, and 15 mg
    Company: Able Laboratories, Inc. Approved: August 25, 2004
  • Haloperidol Injection USP (Preservative-Free) 5 mg (base)/mL; packaged in 5 mg (base)/1 mL syringes, single-use vials, and 50 mg (base)/10 mL multiple-dose vials
    Company: Apotex Corp. Approved: August 25, 2004
  • Minoxidil Topical Solution USP (For Men) (OTC) 5%
    Company: Harmony Labs, Inc. Approved: August 24, 2004
  • Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg, 100 mg/25 mg, and 100 mg/50 mg
    Company: Mylan Pharmaceuticals, Inc. Approved: August 20, 2004
  • Loratadine Oral Solution USP (OTC) 5 mg/5 mL
    Company: Taro Pharmaceutical Industries Ltd. Approved: August 20, 2004
  • Loratadine Oral Solution USP (OTC) 5 mg/5 mL
    Company: Morton Grove Pharmaceuticals, Inc. Approved: August 20, 2004
  • Loratadine Oral Solution USP (OTC) 5 mg/5 mL
    Company: Ranbaxy Laboratories Limited Approved: August 20, 2004
  • Loratadine Oral Solution USP (OTC) 5 mg/5 mL
    Company: L. Perrigo Company Approved: August 20, 2004
  • Nitrofurantoin Capsules USP (macrocrystals) 100 mg
    Company: Mylan Pharmaceuticals, Inc. Approved: August 18, 2004
  • Milrinone Lactate in 5% Dextrose Injection 20 mg (base)/100 mL single-dose plastic container
    Company: B. Braun Medical, Inc. Approved: August 18, 2004
  • Potassium Chloride Extended-Release Tablets USP 20 mEq
    Company: Eurand Inc. Approved: August 18, 2004
  • Methylprednisolone Sodium Succinate For Injection USP 1 gram (base)/vial
    Company: American Pharmaceutical Partners, Inc. Approved: August 12, 2004
  • Levocarnitine Oral Solution USP 1 g/10 mL
    Company: Lyne Laboratories, Inc. Approved: August 10, 2004
  • Esmolol Hydrochloride Injection 10 mg/mL; Packaged In 100 mg/10 mL Single-Dose Vials Company: Bedford Laboratories Approved: August 10, 2004
  • Nitroglycerin Transdermal System 0.2 mg/hour and 0.4 mg/hour
    Company: Schwarz Pharma, Inc. Approved: August 10, 2004
  • Ciclopirox Topical Suspension USP, 0.77% (Lotion)
    Company: Altana, Inc. Approved: August 6, 2004
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