| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-833 |
METOLAZONE TABLETS, USP 5 MG |
TEVA PHARMACEUTICALS USA |
3/1/2004 |
| 2 |
75-006 |
CHLORHEXIDINE GLUCONATE ORAL RINSE, USP 0.12% |
MORTON GROVE PHARMACEUTICALS, INC. |
3/3/2004 |
| 3 |
75-989 |
LORATADINE AND PSEUDOEPHEDRINE SULFATE
EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION) (OTC) |
IMPAX LABORATORIES, INC. |
3/4/2004 |
| 4 |
75-716 |
PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE),
20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE) |
ALPHAPHARM PTY. LTD. |
3/8/2004 |
| 5 |
75-566 |
PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE),
20 MG (BASE), 30 MG (BASE) AND 40 MG (BASE) |
SANDOZ INC. |
3/8/2004 |
| 6 |
40-521 |
PHENYTOIN ORAL SUSPENSION, USP 125 MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
3/8/2004 |
| 7 |
76-168 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 80 MG |
TEVA PHARMACEUTICALS USA |
3/23/2004 |
| 8 |
65-162 |
AMOXICILLIN & CLAVULANATE POTASSIUM FOR ORAL
SUSPENSION, US 600 MG/42.9 MG (BASE)/5 ML |
TEVA PHARMACEUTICALS USA |
3/12/2004 |
| 9 |
40-503 |
HYDROCORTISONE CREAM, USP 2.5% |
VINTAGE PHARMACEUTICALS, LLC |
3/12/2004 |
| 10 |
76-518 |
NAPROXEN SODIUM & PSEUDOEPHEDRINE HCL
EXTENDED-RELEASE TABLE 200 MG (BASE)/120 MG |
L. PERRIGO COMPANY |
3/17/2004 |
| 11 |
76-019 |
DEFEROXAMINE MESYLATE FOR INJECTION, USP 500
MG/VIAL AND 2 G/VIAL |
ABBOTT LABORATORIES |
3/17/2004 |
| 12 |
40-524 |
PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25
MG/ML AND 50 MG/ML PACKAGED IN 1 ML AMPULES |
BEDFORD LABORATORIES |
3/17/2004 |
| 13 |
76-561 |
DICLOFENAC POTASSIUM TABLETS 50 MG |
TORPHARM, INC. |
3/18/2004 |
| 14 |
76-642 |
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 5
MG/200 MG |
INTERPHARM, INC. |
3/18/2004 |
| 15 |
75-923 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 10 MG, 20 MG, AND 40 MG |
ENDO PHARMACEUTICALS, INC. |
3/23/2004 |
| 16 |
65-177 |
COLISTIMETHATE FOR INJECTION, USP 150 MG
(BASE)/VIAL |
PADDOCK LABORATORIES, INC. |
3/19/2004 |
| 17 |
65-194 |
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG
(BASE), AND 300 MG (BASE) |
COREPHARMA LLC |
3/22/2004 |
| 18 |
76-648 |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
CAPSULES 100 MG |
MYLAN PHARMACEUTICALS, INC. |
3/22/2004 |
| 19 |
65-094 |
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150
MG AND 300 MG |
IMPAX LABORATORIES, INC. |
3/22/2004 |
| 20 |
75-414 |
NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG
|
MARTEC SCIENTIFIC, INC. |
3/23/2004 |
| 21 |
76-335 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18
MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG PACKAGED AS
A TRIPHASIC REGIMEN (28-DAY CYCLE) |
ANDRX PHARMACEUTICALS, LLC |
3/26/2004 |
| 22 |
76-796 |
FUROSEMIDE TABLETS, USP 20 MG, 40 MG, AND 80 MG
|
VINTAGE PHARMACEUTICALS, LLC |
3/26/2004 |
| 23 |
76-585 |
MICONAZOLE NITRATE SUPPOSITORIES & MICONAZOLE
NITRATE CREAM 100 MG/2% (COMBINATION PACKAGE) (OTC) |
G & W LABORATORIES, INC. |
3/26/2004 |
| 24 |
65-112 |
ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL,
USP 3%/5% |
ATRIX LABORATORIES, INC. |
3/29/2004 |
| 25 |
76-357 |
MICONAZOLE NITRATE CREAM 4% & MICONAZOLE
NITRATE CREAM 2% 4%/2% (COMBINATION PACKAGE) (OTC) |
L. PERRIGO COMPANY |
3/30/2004 |
| 26 |
76-374 |
QUINAPRIL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
TABLETS 10 MG (BASE)/12.5 MG, 20 MG (BASE)/12.5 MG, AND 20 MG
(BASE)/25 MG |
AMIDE PHARMACEUTICAL, INC. |
3/31/2004 |
| 27 |
65-184 |
CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1%
(BASE) |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
3/31/2004 |
