| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
65-080 |
AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG
AND 400 MG |
RANBAXY LABORATORIES LIMITED |
8/11/2003 |
| 2 |
76-134 |
LORATADINE TABLETS (OTC) 10 MG |
RANBAXY LABORATORIES LIMITED |
8/18/2003 |
| 3 |
76-453 |
LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5% |
ALTANA INC. |
8/18/2003 |
| 4 |
76-154 |
LORATADINE TABLETS (OTC) 10 MG |
GENPHARM INC. |
8/20/2003 |
| 5 |
65-083 |
CEFPODOXIME PROXETIL TABLETS 100 MG (BASE) AND
200 MG (BASE) |
RANBAXY LABORATORIES, INC. |
8/20/2003 |
| 6 |
76-546 |
TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP
300 MG |
AMIDE PHARMACEUTICAL, INC. |
8/20/2003 |
| 7 |
76-366 |
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP
450 MG |
BARR LABORATORIES, INC. |
8/21/2003 |
| 8 |
76-528 |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE &
CODEINE PHOSPHATE CAPS 50 MG/325 MG/40 MG/30 MG |
ABLE LABORATORIES, INC. |
8/21/2003 |
| 9 |
40-481 |
DIGOXIN INJECTION, USP 0.25 MG/ML; PACKAGED IN
0.5 MG/2 ML AMPULES |
SABEX 2002 INC. |
8/21/2003 |
| 10 |
75-715 |
FAMOTIDINE TABLETS (CHEWABLE) (OTC) 10 MG
|
L. PERRIGO COMPANY |
8/22/2003 |
| 11 |
76-544 |
NAPROXEN SODIUM TABLETS, USP 275 MG (250 MG
BASE) AND 550 MG (500 MG BASE) |
ABLE LABORATORIES, INC. |
8/22/2003 |
| 12 |
40-513 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS,
USP 50 MG/500 MG/40 MG |
VINTAGE PHARMACEUTICALS, INC. |
8/25/2003 |
| 13 |
76-214 |
SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120
MG, AND 160 MG |
TORPHARM |
8/27/2003 |
| 14 |
76-320 |
LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5% |
ATRIX LABORATORIES, INC. |
8/27/2003 |
| 15 |
40-511 |
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
TABLETS, USP 50 MG/325 MG/40 MG |
VINTAGE PHARMACEUTICALS, INC. |
8/27/2003 |
| 16 |
76-570 |
TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES, USP
300 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
8/28/2003 |
| 17 |
76-349 |
FLUDARABINE PHOSPHATE FOR INJECTION, USP 50
MG/SINGLE-DOSE VIAL |
SICOR PHARMACEUTICALS |
8/28/2003 |
| 18 |
76-234 |
FLAVOXATE HYDROCHLORIDE TABLETS 100 MG |
IMPAX LABORATORIES, INC. |
8/28/2003 |
| 19 |
40-516 |
CHLOROQUINE PHOSPHATE TABLETS, USP 500 MG (300
MG BASE) |
IMPAX LABORATORIES, INC. |
8/29/2003 |
| 20 |
40-508 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL
SOLUTION 10 MG/500 MG PER 15 ML |
MALLINCKRODT INC. |
8/29/2003 |
