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

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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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