| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
65-161 |
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
12/3/2003 |
| 2 |
76-656 |
FENOLDOPAM MESYLATE INJECTION, USP 10 MG
(BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 20 MG (BASE)/2 ML
SINGLE-DOSE AMPULES |
PHARMAFORCE, INC. |
12/1/2003 |
| 3 |
76-508 |
BETAMETHASONE DIPROPIONATE GEL (AUGMENTED)
0.05% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
12/2/2003 |
| 4 |
65-159 |
AMOXICILLIN TABLETS FOR ORAL SUSPENSION, USP
600 MG |
RANBAXY LABORATORIES LIMITED |
12/4/2003 |
| 5 |
76-461 |
VINORELBINE TARTRATE INJECTION 10 MG
(BASE)/ML, PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG (BASE)/5 ML
SINGLE-USE VIALS. |
BEDFORD LABORATORIES |
12/11/2003 |
| 6 |
76-592 |
BETAMETHASONE DIPROPIONATE CREAM, USP
(AUGMENTED) 0.05% (BASE) |
CLAY-PARK LABS, INC. |
12/9/2003 |
| 7 |
76-215 |
BETAMETHASONE DIPROPIONATE CREAM, USP
(AUGMENTED) 0.05% (BASE) |
ALTANA, INC. |
12/9/2003 |
| 8 |
76-543 |
BETAMETHASONE DIPROPIONATE CREAM, USP
(AUGMENTED) 0.05% (BASE) |
TARO PHARMACEUTICALS USA, INC. |
12/9/2003 |
| 9 |
76-282 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE)
AND 4 MG (BASE) |
ALPHAPHARM PTY. LTD. |
12/16/2003 |
| 10 |
76-666 |
INDOMETHACIN CAPSULES, USP 25 MG AND 50 MG |
ABLE LABORATORIES, INC. |
12/17/2003 |
| 11 |
76-307 |
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS 15
MG AND 30 MG |
BARR LABORATORIES, INC. |
12/17/2003 |
| 12 |
76-732 |
METOLAZONE TABLETS, USP 2.5 MG |
EON LABS, INC. |
12/19/2003 |
| 13 |
76-466 |
METOLAZONE TABLETS, USP 5 MG AND 10 MG |
EON LABS, INC. |
12/19/2003 |
| 14 |
40-506 |
ETHOSUXIMIDE SYRUP 250 MG/5 ML |
MIKART, INC. |
12/22/2003 |
| 15 |
76-244 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
IVAX PHARMACEUTICALS, INC. |
12/22/2003 |
| 16 |
65-092 |
CEFACLOR TABLETS (CHEWABLE) 125 MG, 187 MG,
250 MG, AND 375 MG |
RANBAXY LABORATORIES LIMITED |
12/22/2003 |
| 17 |
40-496 |
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
TABLETS, USP 50 MG/750 MG/40 MG, RESPECTIVELY |
MIKART, INC. |
12/23/2003 |
| 18 |
76-698 |
METOLAZONE TABLETS, USP 2.5 MG |
MYLAN PHARMACEUTICALS, INC. |
12/23/2003 |
| 19 |
75-543 |
METOLAZONE TABLETS, USP 10 MG |
TEVA PHARMACEUTICALS USA |
12/24/2003 |
| 20 |
75-808 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
0.180 MG/0.035 MG, 0.215 MG/0.035 MG, 0.250 MG/0.035 MG,
PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE) |
BARR LABORATORIES, INC. |
12/29/2003 |
| 21 |
76-392 |
MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG |
BARR LABORATORIES, INC. |
12/29/2003 |
| 22 |
76-604 |
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
7.5 MG/200 MG |
ANDRX PHARMACEUTICALS, LLC |
