 |
Tentative
Approvals - February 2004
| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
75-896 |
FELODIPINE EXTENDED-RELEASE TABLETS 2.5 MG, 5 MG, AND 10 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
2/6/2004 |
| 2 |
76-593 |
CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG,
500 MG, AND 750 MG |
EON LABS, INC. |
2/10/2004 |
| 3 |
75-821 |
FAMOTIDINE TABLETS (CHEWABLE) 10 MG |
TEVA PHARMACEUTICALS USA |
2/12/2004 |
| 4 |
75-566 |
PAROXETINE HYDROCHLORIDE TABLETS 10 MG
(BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE) |
SANDOZ, INC. |
2/18/2004 |
| 5 |
76-595 |
MODAFINIL TABLETS 100 MG 200 MG |
RANBAXY PHARMACEUTICALS, INC. |
2/18/2004 |
| 6 |
76-484 |
CIPROFLOXACIN INJECTION, USP 10 MG/ML;
PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/19/2004 |
| 7 |
76-611 |
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 |
BEDFORD LABORATORIES |
2/19/2004 |
| 8 |
76-695 |
ONDANSETRON INJECTION, USP 2 MG/ML; PACKAGED
IN 40 MG/20 ML MULTIPLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
2/26/2004 |
| 9 |
76-483 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND
40 MG |
EON LABS, INC. |
2/26/2004 |
| 10 |
76-696 |
ONDANSETRON INJECTION, USP
(PRESERVATIVE-FREE) 2 MG/ML, PACKAGED IN 4 MG/2 ML SINGLE-DOSE
VIALS |
MAYNE PHARMA (USA), INC. |
2/26/2004 |
| 11 |
76-298 |
FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL
EXTENDED-RELEASE TABL 60 MG/120 MG |
IMPAX LABORATORIES, INC. |
2/27/2004 |
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Date created: 3/4/2004 |
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