| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
75-987 |
OXAPROZIN TABLETS, USP 600 MG |
TORPHARM, INC. |
9/2/2004 |
| 2 |
76-352 |
AMANTADINE HYDROCHLORIDE SYRUP, USP 50
MG/ 5 ML |
SILARX PHARMACEUTICALS, INC. |
9/10/2004 |
| 3 |
76-372 |
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION
0.2% |
IVAX PHARMACEUTICALS, INC. |
9/10/2004 |
| 4 |
76-639 |
CIPROFLOXACIN TABLETS, USP 250 MG, 500
MG, AND 750 MG |
UNIQUE PHARMACEUTICAL LABORATORIES |
9/10/2004 |
| 5 |
76-865 |
FLUTICASONE PROPIONATE CREAM 0.05% |
KV PHARMACEUTICAL COMPANY |
9/10/2004 |
| 6 |
76-775 |
NICOTINE POLACRILEX GUM, USP (OTC) 2 MG
(BASE) REGULAR FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 7 |
76-776 |
NICOTINE POLACRILEX GUM, USP (OTC) 2 MG
(BASE) ORANGE FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 8 |
76-777 |
NICOTINE POLACRILEX GUM, USP (OTC) 2 MG
(BASE) MINT FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 9 |
76-778 |
NICOTINE POLACRILEX GUM, USP (OTC) 4 MG
(BASE) ORANGE FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 10 |
76-779 |
NICOTINE POLACRILEX GUM, USP (OTC) 4 MG
(BASE) MINT FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 11 |
76-789 |
NICOTINE POLACRILEX GUM, USP (OTC) 4 MG
(BASE) REGULAR FLAVOR |
L. PERRIGO COMPANY |
9/16/2004 |
| 12 |
40-510 |
ERGOTAMINE TARTRATE AND CAFFEINE TABLETS,
USP 1 MG/100 MG |
WEST-WARD PHARMACEUTICAL CORP. |
9/17/2004 |
| 13 |
65-133 |
CYCLOSPORIN ORAL SOLUTION, USP 100 MG/ML
|
MORTON GROVE PHARMACEUTICALS, INC. |
9/17/2004 |
| 14 |
76-751 |
MESALAMINE RECTAL SUSPENSION, USP (ENEMA)
4 G/60 ML |
AGIS INDUSTRIES (1983), LTD. |
9/17/2004 |
| 15 |
76-729 |
CARBAMAZEPINE ORAL SUSPENSION, USP 100
MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
9/20/2004 |
| 16 |
76-858 |
LEVOCARNITINE TABLETS, USP 330 MG |
COREPHARMA LLC |
9/20/2004 |
| 17 |
76-427 |
MILRINONE LACTATE INJECTION 1 MG
(BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG
(BASE)/20 ML SINGLE-DOSE VIALS |
APOTEX CORP. |
9/21/2004 |
| 18 |
76-557 |
LORATADINE AND PSEUDOEPHEDRINE SULFATE
EXTENDED-RELEASE TABL 10 MG/240 MG (OTC) (24-HOUR
FORMULATION) |
RANBAXY LABORATORIES LIMITED |
9/22/2004 |
| 19 |
76-925 |
IBUPROFEN ORAL SUSPENSION, USP 100 MG/5
ML |
PERRIGO R & D COMPANY |
9/23/2004 |
| 20 |
65-174 |
CLARITHROMYCIN TABLETS, USP 250 MG AND
500 MG |
RANBAXY LABORATORIES LIMITED |
9/24/2004 |
| 21 |
65-206 |
CLINDAMYCIN INJECTION, USP 150 MG/ML
(PHARMACY BULK PACKAGE) |
BEDFORD LABORATORIES |
9/24/2004 |
| 22 |
76-962 |
BROMOCRIPTINE MESYLATE TABLETS, USP 2.5
MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
9/24/2004 |
| 23 |
40-415 |
WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG,
2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG |
GENPHARM INC. |
9/27/2004 |
| 24 |
76-318 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 80 MG |
IMPAX LABORATORIES, INC. |
9/27/2004 |
| 25 |
76-068 |
DEXRAZOXANE FOR INJECTION 250 MG AND 500
MG; PACKAGED IN SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
9/28/2004 |
| 26 |
76-464 |
HALOPERIDOL INJECTION, USP 5 MG/ML;
PACKAGED IN 1 ML AMPULES |
SABEX 2002 INC. |
9/29/2004 |
| 27 |
76-783 |
NORETHINDRONE AND ETHINYL ESTRADIOL
TABLETS, USP 0.5 MG/0.035 MG AND 1 MG/0.035 MG (28-DAY
REGIMEN) (ARANELLE TABLETS) |
BARR LABORATORIES, INC. |
9/29/2004 |
| 28 |
76-911 |
CLORAZEPATE DIPOTASSIUM TABLETS, USP 3.75
MG, 7.5 MG, AND 15 MG |
RANBAXY LABORATORIES LIMITED |
9/29/2004 |
| 29 |
40-522 |
NOREPINEPHRINE BITARTRATE INJECTION, USP
1 MG (BASE)/ML; PACKAGED IN 4 MG (BASE)/4 ML AMPOULES |
PHARMAFORCE, INC. |
9/30/2004 |
| 30 |
76-321 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG
(BASE) AND 4 MG (BASE) |
IVAX PHARMACEUTICALS, INC. |
9/30/2004 |
| 31 |
76-841 |
MESALAMINE RECTAL SUSPENSION, USP (ENEMA)
4 G/60 ML |
TEVA PHARMACEUTICALS USA |
9/30/2004 |
