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Tentative Approvals - July 2004
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-706 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
APOTEX INC. |
7/1/2004 |
| 2 |
76-236 |
FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL
EXTENDED-RELEASE TABL 60 MG/120 MG |
BARR LABORATORIES, INC. |
7/1/2004 |
| 3 |
76-591 |
MOMETASONE FUROATE CREAM, USP 0.1% |
ATRIX LABORATORIES, INC. |
7/13/2004 |
| 4 |
76-540 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG
(BASE), 50 MG (BASE), AND 100 MG (BASE) |
GENPHARM INC. |
7/14/2004 |
| 5 |
76-651 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE),
10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
7/15/2004 |
| 6 |
76-665 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG,
AND 200 MG |
APOTEX INC. |
7/20/2004 |
| 7 |
76-573 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML;
PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
7/20/2004 |
| 8 |
76-871 |
MITOXANTRONE INJECTION, USP (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML,
25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
7/23/2004 |
| 9 |
76-731 |
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG,
AND 5 MG/500 MG |
COREPHARMA LLC |
7/30/2004 |
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Date created: August 4, 2004  |
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