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Tentative Approvals - March
2004
| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-558 |
CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG |
HIKMA PHARMACEUTICALS |
3/2/2004 |
| 2 |
76-509 |
FENOFIBRATE TABLETS 54 MG AND 160 MG |
IMPAX LABORATORIES, INC. |
3/5/2004 |
| 3 |
76-433 |
FENOFIBRATE TABLETS 54 MG AND 160 MG |
TEVA PHARMACEUTICALS USA |
3/5/2004 |
| 4 |
76-459 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
3/9/2004 |
| 5 |
76-607 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
3/12/2004 |
| 6 |
76-657 |
IFOSFAMIDE INJECTION 50 MG/ML; PACKAGED IN 1 G/20 ML AND 3 G/60 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
3/17/2004 |
| 7 |
76-077 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
IVAX PHARMACEUTICALS, INC. |
3/17/2004 |
| 8 |
76-642 |
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG |
INTERPHARM, INC. |
3/18/2004 |
| 9 |
76-517 |
CARBOPLATIN INJECTION 10 MG/ML, PACKAGED IN 50 MG/5 ML, 150 MG/15 ML,
AND 450 MG/45 ML SINGLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
3/30/2004 |
| 10 |
76-288 |
RISPERIDONE TABLETS 0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, AND 4 MG |
MYLAN PHARMACEUTICALS, INC. |
3/31/200 |
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Date created: April 5, 2004 |
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