| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
77-226 |
BROMOCRIPTINE MESYLATE CAPSULES, USP 5 MG
(BASE) |
MYLAN PHARMACEUTICALS, INC. |
4/4/2005 |
| 2 |
77-066 |
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS
CAPSULES 100 MG |
EON LABS, INC. |
4/5/2005 |
| 3 |
75-360 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND
400 MG |
APOTEX INC. |
4/6/2005 |
| 4 |
75-539 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND
400 MG |
EON PHARMA, LLC |
4/6/2005 |
| 5 |
77-180 |
MOMETASONE FUROATE TOPICAL SOLUTION, USP
0.1% |
AIGIS INDUSTRIES LTD. |
4/6/2005 |
| 6 |
76-171 |
MOMETASONE FUROATE CREAM, USP 0.1% |
ALTANA INC. |
4/8/2005 |
| 7 |
76-330 |
OCTREOTIDE ACETATE INJECTION 0.2 MG/ML
(BASE) 1 MG/ML (BASE) |
BEDFORD LABORATORIES |
4/8/2005 |
| 8 |
77-069 |
AMIODARONE HYDROCHLORIDE TABLETS 200 MG
400 MG |
AUROSAL PHARMACEUTICALS, LLC. |
4/8/2005 |
| 9 |
76-942 |
KETOCONAZOLE SHAMPOO 2 % |
QLT USA, INC. |
4/11/2005 |
| 10 |
76-790 |
CICLOPIROX OLAMINE CREAM, USP 0.77% |
TARO PHARMACEUTICALS USA, INC. |
4/12/2005 |
| 11 |
76-864 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
TEVA PHARMACEUTICALS USA |
4/12/2005 |
| 12 |
76-869 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
ANDRX PHARMACEUTICALS, LLC |
4/12/2005 |
| 13 |
76-878 |
METFORMIN HYDROCHLORIDE EXTENDED-REAEASE
750 MG |
PUREPAC PHARMACEUTICAL CO |
4/13/2005 |
| 14 |
76-236 |
FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL
EXTENDED-RELEASE TAB 60 MG/120 MG |
BARR LABORATORIES, INC. |
4/14/2005 |
| 15 |
76-250 |
NIACIN EXTENDED-RELEASE TABLETS 1000 MG |
BARR LABORATORIES, INC. |
4/14/2005 |
| 16 |
40-555 |
PHENTERMINE HYDROCHLORIDE TABLETS, USP
37.5 MG |
LANNETT HOLDINGS, INC. |
4/15/2005 |
| 17 |
76-417 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
WATSON LABORATORIES, INC. |
4/18/2005 |
| 18 |
76-468 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
IVAX PHARMACEUTICALS, INC. |
4/18/2005 |
| 19 |
76-489 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
ROXANE LABORATORIES, INC. |
4/18/2005 |
| 20 |
76-530 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
BARR LABORATORIES, INC. |
4/18/2005 |
| 21 |
76-683 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
EON LABS, INC. |
4/18/2005 |
| 22 |
76-811 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
4/18/2005 |
| 23 |
76-849 |
VINORELBINE TARTRATE INJECTION 10 MG
(BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG
(BASE)/5 ML SINGLE-USE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/18/2005 |
| 24 |
76-910 |
ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG
(BASE) AND 1 MG (BASE) |
IMPAX LABORATORIES, INC. |
4/18/2005 |
| 25 |
77-064 |
METFORMIN HYDROCHLORIDE TABLETS 500 MG,
850 MG, AND 1000 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
4/18/2005 |
| 26 |
74-848 |
PROPOFOL INJECTABLE EMULSION 10 MG/ML;
PACKAGED IN 20 ML, 50 ML, AND 100 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
4/19/2005 |
| 27 |
77-060 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
ZYDUS PHARMACEUTICALS USA INC. |
4/20/2005 |
| 28 |
77-161 |
AMIODARONE HYDROCHLORIDE INJECTION 50
MG/ML |
APOTEX CORP. |
4/20/2005 |
| 29 |
77-222 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,
AND 40 MG |
INVAGEN PHARMACEUTICALS, INC. |
4/20/2005 |
| 30 |
65-226 |
CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL
AND 1 G/VIAL |
ORCHID HEALTHCARE |
4/21/2005 |
| 31 |
76-475 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS 37.5 MG/325 MG |
KALI LABORATORIES, INC. |
4/21/2005 |
| 32 |
77-078 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
4/21/2005 |
| 33 |
40-572 |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION,
USP 10 MG/ML (AS DEXAMETHASONE PHOSPHATE) (PRESERVED)
MULTIPLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/22/2005 |
| 34 |
76-913 |
PREDNISOLONE SODIUM PHOSPHATE ORAL
SOLUTION 15 MG (BASE)/5 ML |
PHARMACEUTICAL ASSOCIATES, INC. |
4/25/2005 |
| 35 |
75-162 |
CLOZAPINE TABLETS, USP 25 MG AND 100 MG |
TEVA PHARMACEUTICALS USA |
4/26/2005 |
| 36 |
76-378 |
NIACIN EXTENDED-RELEASE TABLETS 500 MG
AND 750 MG |
BARR LABORATORIES, INC. |
4/26/2005 |
| 37 |
77-133 |
ADENOSINE INJECTION, USP 3 MG/ML;
PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-USE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/27/2005 |
| 38 |
77-339 |
NAPROXEN TABLETS, USP 250 MG, 375 MG, AND
500 MG |
PERRIGO R&D COMPANY |
4/27/2005 |
| 39 |
77-075 |
NORETHINDRONE ACETATE AND ETHINYL
ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS 1.5
MG/0.03 MG/75 MG |
ANDRX PHARMACEUTICALS, LLC |
4/28/2005 |
| 40 |
76-812 |
ESTRADIOL AND ESTRADIOL/NORGESTIMATE
TABLETS 1 MG AND 1 MG/0.09 MG |
BARR LABORATORIES, INC. |
4/29/2005 |
| 41 |
77-045 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
AKYMA PHARMACEUTICALS, LLC |
4/29/2005 |
