Drugs
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Approvals - April 2005
| 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 |
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