| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-391 |
ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE) |
NOVEX PHARMA |
4/1/2003 |
| 2 |
76-371 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG
(BASE) |
BARR LABORATORIES, INC. |
4/9/2003 |
| 3 |
75-883 |
AMMONIUM LACTATE CREAM 12% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
4/10/2003 |
| 4 |
75-401 |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) |
ANDRX PHARMACEUTICALS, L.L.P. |
4/10/2003 |
| 5 |
76-023 |
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200
MG |
TEVA PHARMACEUTICALS USA |
4/11/2003 |
| 6 |
40-504 |
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG,
AND 25 MG |
ABLE LABORATORIES, INC. |
4/11/2003 |
| 7 |
76-356 |
ISOTRETINOIN CAPSULES, USP 10 MG |
BARR LABORATORIES, INC. |
4/11/2003 |
| 8 |
76-135 |
ISOTRETINOIN CAPSULES, USP 20 MG AND 40 MG |
BARR LABORATORIES, INC. |
4/11/2003 |
| 9 |
40-491 |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP EQ. TO 10
MG DEXAMETHASONE PHOSPHATE/ML (PRESERVATIVE-FREE) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/11/2003 |
| 10 |
65-131 |
MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG (BASE), 75
MG (BASE), AND 100 MG (BASE) |
PAR PHARMACEUTICAL, INC. |
4/16/2003 |
| 11 |
76-156 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03%
(0.021 MG/SPRAY) |
NOVEX PHARMA |
4/18/2003 |
| 12 |
76-155 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.06%
(0.042 MG/SPRAY) |
NOVEX PHARMA |
4/18/2003 |
| 13 |
76-369 |
PERMETHRIN CREAM 5% |
CLAY-PARK LABS, INC. |
4/21/2003 |
| 14 |
40-467 |
TRIAMCINOLONE ACETONIDE LOTION, USP 0.025% AND 0.1% |
ALTANA, INC. |
4/21/2003 |
| 15 |
76-382 |
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MG |
ABLE LABORATORIES, INC. |
4/21/2003 |
| 16 |
40-502 |
PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG |
IMPAX LABORATORIES, INC. |
4/24/2003 |
| 17 |
65-118 |
CEFUROXIME AXETIL TABLETS, USP 125 MG (BASE), 250 MG
(BASE), AND 500 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
4/25/2003 |
| 18 |
40-458 |
CARBINOXAMINE MALEATE ORAL SOLUTION 4 MG/5 ML |
MIKART, INC. |
4/25/2003 |
| 19 |
76-394 |
AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED
IN 150 MG/3 ML SINGLE-USE VIALS |
APOTEX CORP. |
4/25/2003 |
| 20 |
76-444 |
HYDROMORPHONE HYDROCHLORIDE INJECTION, USP 10 MG/ML;
PACKAGED IN 10 MG/1 ML, 50 MG/5 ML, AND 500 MG/50 ML SINGLE-USE VIALS |
FAULDING PHARMACEUTICAL COMPANY |
4/25/2003 |
| 21 |
74-504 |
TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG
(BASE) |
TEVA PHARMACEUTICALS, USA |
4/28/2003 |
| 22 |
40-475 |
DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML;
SINGLE-DOSE AMPULES |
PADDOCK LABORATORIES, INC. |
4/28/2003 |
| 23 |
75-862 |
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1
MG AND 0.02 MG, RESPECTIVELY, (21- AND 28-DAY REGIMENS) |
BARR LABORATORIES, INC. |
4/29/2003 |
