| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-691 |
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS,
USP 450 MG |
ROXANE LABORATORIES, INC. |
1/5/2004 |
| 2 |
76-600 |
METOLAZONE TABLETS, USP 2.5 MG |
TEVA PHARMACEUTICALS USA |
1/6/2004 |
| 3 |
76-334 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
0.25 MG/0.035 MG |
ANDRX PHARMACEUTICALS, LLC |
1/9/2004 |
| 4 |
65-156 |
MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG
(BASE) 75 MG (BASE) 100 MG (BASE) |
RANBAXY LABORATORIES LIMITED |
1/6/2004 |
| 5 |
76-419 |
KETOCONAZOLE SHAMPOO 2% |
CLAY-PARK LABS, INC. |
1/7/2004 |
| 6 |
40-538 |
PREDNISONE TABLETS, USP 2.5 MG |
WEST-WARD PHARMACEUTICAL CORP. |
1/8/2004 |
| 7 |
65-046 |
CEFUROXIME FOR INJECTION, USP 7.5 G/100 ML
PHARMACY BULK PACKAGE |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
1/9/2004 |
| 8 |
65-048 |
CEFUROXIME FOR INJECTION, USP 750 MG/10 ML &
1.5 G/20 ML VIALS; AND 750 MG/100 ML & 1.5 G/100 ML
INTRAVENOUS INFUSION VIALS |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
1/9/2004 |
| 9 |
75-739 |
MESNA INJECTION 100 MG/ML, PACKAGED IN 1G/10
ML MULTIPLE-DOSE VIALS |
BEDFORD LABORATORIES |
1/9/2004 |
| 10 |
76-364 |
HYDROCORTISONE BUTYRATE TOPICAL SOLUTION 0.1%
|
TARO PHARMACEUTICAL INDUSTRIES LTD. |
1/14/2004 |
| 11 |
76-494 |
NAPROXEN TABLETS, USP 250 MG, 375 MG, AND 500
MG |
WEST-WARD PHARMACEUTICAL CORP |
1/14/2004 |
| 12 |
75-924 |
DOXEPIN HYDROCHLORIDE ORAL SOLUTION, USP
(CONCENTRATE) 10 MG (BASE)/ML |
PHARMACEUTICAL ASSOCIATES, INC. |
1/15/2004 |
| 13 |
76-512 |
CYTARABINE INJECTION 100 MG/ML; PACKAGED IN 2
G/20 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
1/15/2004 |
| 14 |
76-670 |
METOPROLOL TARTRATE TABLETS, USP 25 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
1/15/2004 |
| 15 |
76-533 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE),
AND 4 MG (BASE) |
TORPHARM, INC. |
1/16/2004 |
| 16 |
76-359 |
IBUPROFEN CHEWABLE TABLETS 50 MG (ORANGE &
GRAPE FLAVORED), AND 100 MG (ORANGE & GRAPE FLAVORED) |
L. PERRIGO COMPANY |
1/16/2004 |
| 17 |
75-816 |
CALCITRIOL INJECTION 0.001 MG/ML,AND 0.002
MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
1/16/2004 |
| 18 |
76-704 |
METOPROLOL TARTRATE TABLETS, USP 25 MG, 50
MG, AND 100 MG |
MYLAN PHARMACEUTICALS, INC. |
1/16/2004 |
| 19 |
65-146 |
CEFACLOR CAPSULES, USP 250 MG AND 500 MG |
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO. |
1/22/2004 |
| 20 |
76-603 |
BETAMETHASONE DIPROPIONATE CREAM, USP
(AUGMENTED) 0.05% (BASE) |
ATRIX LABORATORIES, INC. |
1/23/2004 |
| 21 |
75-913 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 100 MG |
IMPAX LABORATORIES, INC. |
1/28/2004 |
| 22 |
76-208 |
LORATADINE AND PSEUDOEPHEDRINE SULFATE
EXTENDED-RELEASE TABS 5 MG/120 MG (12 HOUR FORMULATION) |
ANDRX PHARMACEUTICALS, INC. |
1/28/2004 |
| 23 |
76-522 |
METRONIDAZOLE CAPSULES 375 MG |
KALI LABORATORIES, INC. |
1/29/2004 |
| 24 |
65-121 |
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP
0.3% (BASE) |
ALTANA INC. |
1/30/2004 |
