| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-039 |
CARBOPLATIN INJECTION 10 MG/ML |
BEDFORD LABORATORIES |
6/6/2003 |
| 2 |
76-086 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
GENEVA PHARMACEUTICALS, INC. |
6/10/2003 |
| 3 |
75-763 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG |
IVAX PHARMACEUTICALS, INC. |
6/11/2003 |
| 4 |
40-486 |
METAXALONE TABLETS 400 MG |
COREPHARMA LLC |
6/11/2003 |
| 5 |
76-049 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
ANDRX PHARMACEUTICALS, LLC |
6/11/2003 |
| 6 |
76-378 |
NIACIN EXTENDED-RELEASE TABLETS 500 MG, AND 750 MG |
BARR LABORATORIES, INC. |
6/13/2003 |
| 7 |
76-220 |
OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG |
RANBAXY LABORATORIES LIMITED |
6/17/2003 |
| 8 |
76-304 |
FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML
AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS |
ABBOTT LABORATORIES |
6/18/2003 |
| 9 |
76-303 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML
AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS |
ABBOTT LABORATORIES |
6/18/2003 |
| 10 |
76-456 |
ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2500 MG/10 ML AMPULES FOR DILUTION |
PHARMAFORCE, INC. |
6/26/2003 |
| 11 |
76-474 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS |
PHARMAFORCE, INC. |
6/26/2003 |
| 12 |
76-397 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
LEK PHARMACEUTICALS D.D. |
6/26/2003 |
| 13 |
76-326 |
ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2,500 MG/10 ML VIALS FOR DILUTION |
BEDFORD LABORATORIES |
6/26/2003 |
| 14 |
76-323 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
6/26/2003 |
