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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-340 FINASTERIDE TABLETS, USP 5 MG   IVAX PHARMACEUTICALS, INC. 1/7/2005 
2 76-644 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 10 MG   MYLAN PHARMACEUTICALS, INC. 1/12/2005 
3 76-702 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 5 MG   MYLAN PHARMACEUTICALS, INC. 1/12/2005 
4 76-812 ESTRADIOL AND ESTRADIOL/NORGESTIMATE TABLETS 1 MG AND 1 MG/0.09 MG   BARR LABORATORIES, INC. 1/13/2005 
5 76-995 GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG   ANDRX PHARMACEUTICALS, LLC 1/19/2005 
6 76-877 GABAPENTIN TABLETS 600 MG AND 800 MG   EON LABS, INC. 1/31/2005 

 

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