Tentative Approvals - May 2003
|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-386 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
RANBAXY LABORATORIES LIMITED |
5/2/2003 |
2 |
76-424 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
PLIVA, INC. |
5/9/2003 |
3 |
76-250 |
NIACIN EXTENDED-RELEASE TABLETS 1000 MG |
BARR LABORATORIES, INC. |
5/9/2003 |
4 |
76-501 |
ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE SYRINGES |
BAXTER HEALTHCARE CORPORATION |
5/14/2003 |
5 |
76-500 |
ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE VIALS |
BAXTER HEALTHCARE CORPORATION |
5/14/2003 |
6 |
76-256 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS |
BEDFORD LABORATORIES |
5/21/2003 |
7 |
76-254 |
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% |
ALCON UNIVERSAL, INC. |
5/29/2003 |
8 |
75-876 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG |
MYLAN PHARMACEUTICALS, INC. |
5/29/2003 |
9 |
76-109 |
KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% |
NOVEX PHARMA |
5/30/2003 |
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FDA/Center for Drug Evaluation and Research
Last Updated: June 4, 2003
Originator: OTCOM/DLIS
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