| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
65-085 |
MUPIROCIN OINTMENT, USP 2% |
TEVA PHARMACEUTICALS USA |
11/7/2003 |
| 2 |
76-526 |
FLUOROURACIL TOPICAL SOLUTION, USP 2% AND 5%
|
TARO PHARMACEUTICAL INDUSTRIES LTD. |
11/5/2003 |
| 3 |
75-990 |
LORATADINE ORALLY DISINTEGRATING TABLETS 10
MG |
ANDRX PHARMACEUTICALS, LLC |
11/3/2003 |
| 4 |
76-478 |
IBUPROFEN/PSEUDOEPHEDRINE HYDROCHLORIDE ORAL
SUSPENSION 100 MG/15 MG PER 5 ML, BERRY, GRAPE, AND BUBBLE
GUM FLAVORS |
PERRIGO COMPANY |
11/5/2003 |
| 5 |
76-598 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL
SPRAY) 0.06% (0.042 MG/SPRAY) |
ROXANE LABORATORIES, INC. |
11/5/2003 |
| 6 |
76-664 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL
SPRAY) 0.03% (0.021 MG/SPRAY) |
ROXANE LABORATORIES, INC. |
11/5/2003 |
| 7 |
75-505 |
LORATADINE SYRUP 5 MG/5 ML |
TEVA PHARMACEUTICALS USA |
11/7/2003 |
| 8 |
65-114 |
PIPERACILLIN FOR INJECTION, USP 2 G, 3 G, AND
4 G PACKAGED IN SINGLE-USE VIALS |
ISTITUTO BIOCHIMICO ITALIANO, S.P.A. |
11/14/2003 |
| 9 |
76-258 |
FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50
mcg/hr, 75mcg/hr, AND 100 mcg/hr |
MYLAN TECHNOLOGIES, INC. |
11/21/2003 |
| 10 |
76-370 |
ALBUTEROL SULFATE INHALATION SOLUTION 0.083%
|
BREATH LIMITED |
11/24/2003 |
| 11 |
75-932 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 100 MG |
EON LABS, INC. |
11/25/2003 |
| 12 |
76-139 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND
40 MG |
TEVA PHARMACEUTICALS USA |
11/25/2003 |
| 13 |
76-460 |
IBUPROFEN TABLETS, USP (OTC) 200 MG |
NEIL LABORATORIES, INC. |
11/26/2003 |
| 14 |
75-563 |
SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG,
160 MG, AND 240 MG |
VINTAGE PHARMACEUTICALS, INC. |
11/7/2003 |
| 15 |
65-123 |
MUPIROCIN OINTMENT, USP 2% |
CLAY-PARK LABS, INC. |
11/7/2003 |
| 16 |
76-505 |
METRONIDAZOLE CAPSULES 375 MG |
ABLE LABORATORIES, INC. |
11/13/2003 |
| 17 |
76-481 |
MOMETASONE FUROATE OINTMENT, USP 0.1% |
ATRIX LABORATORIES, INC. |
11/14/2003 |
