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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-355 ALBUTEROL SULFATE INHALATION SOLUTION, USP 0.042% (BASE) PACKAGED IN 1.5 MG (BASE)/3 ML UNIT-DOSE VIALS NEPHRON PHARMACEUTICALS CORPORATION 11/7/2003 
2 76-118 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   KV PHARMACEUTICAL COMPANY 11/7/2003 
3 76-211 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   TEVA PHARMACEUTICALS USA 11/7/2003 
4 76-507 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG   TARO PHARMACEUTICAL INDUSTRIES, LTD. 11/12/2003 
5 75-477 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   IVAX PHARMACEUTICALS, INC. 11/24/2003 

 

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