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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2005.

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-340FINASTERIDE TABLETS, USP 5 MG  IVAX PHARMACEUTICALS, INC.1/7/2005 
276-644OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 10 MG  MYLAN PHARMACEUTICALS, INC.1/12/2005 
376-702OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 5 MG  MYLAN PHARMACEUTICALS, INC.1/12/2005 
476-812ESTRADIOL AND ESTRADIOL/NORGESTIMATE TABLETS 1 MG AND 1 MG/0.09 MG  BARR LABORATORIES, INC.1/13/2005 
576-995GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  ANDRX PHARMACEUTICALS, LLC1/19/2005 
676-877GABAPENTIN TABLETS 600 MG AND 800 MG  EON LABS, INC.1/31/2005