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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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Date created: February 3, 2005 |
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