Drugs
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Approvals - November 2003
| ANDA Number | Generic Drug Name | Applicant | Approval Date | |
|---|---|---|---|---|
| 1 | 65-085 | MUPIROCIN OINTMENT, USP 2% | TEVA PHARMACEUTICALS USA | 11/7/2003 |
| 2 | 76-526 | FLUOROURACIL TOPICAL SOLUTION, USP 2% AND 5% | TARO PHARMACEUTICAL INDUSTRIES LTD. | 11/5/2003 |
| 3 | 75-990 | LORATADINE ORALLY DISINTEGRATING TABLETS 10 MG | ANDRX PHARMACEUTICALS, LLC | 11/3/2003 |
| 4 | 76-478 | IBUPROFEN/PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SUSPENSION 100 MG/15 MG PER 5 ML, BERRY, GRAPE, AND BUBBLE GUM FLAVORS | PERRIGO COMPANY | 11/5/2003 |
| 5 | 76-598 | IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.06% (0.042 MG/SPRAY) | ROXANE LABORATORIES, INC. | 11/5/2003 |
| 6 | 76-664 | IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) | ROXANE LABORATORIES, INC. | 11/5/2003 |
| 7 | 75-505 | LORATADINE SYRUP 5 MG/5 ML | TEVA PHARMACEUTICALS USA | 11/7/2003 |
| 8 | 65-114 | PIPERACILLIN FOR INJECTION, USP 2 G, 3 G, AND 4 G PACKAGED IN SINGLE-USE VIALS | ISTITUTO BIOCHIMICO ITALIANO, S.P.A. | 11/14/2003 |
| 9 | 76-258 | FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75mcg/hr, AND 100 mcg/hr | MYLAN TECHNOLOGIES, INC. | 11/21/2003 |
| 10 | 76-370 | ALBUTEROL SULFATE INHALATION SOLUTION 0.083% | BREATH LIMITED | 11/24/2003 |
| 11 | 75-932 | BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG | EON LABS, INC. | 11/25/2003 |
| 12 | 76-139 | FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG | TEVA PHARMACEUTICALS USA | 11/25/2003 |
| 13 | 76-460 | IBUPROFEN TABLETS, USP (OTC) 200 MG | NEIL LABORATORIES, INC. | 11/26/2003 |
| 14 | 75-563 | SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MG | VINTAGE PHARMACEUTICALS, INC. | 11/7/2003 |
| 15 | 65-123 | MUPIROCIN OINTMENT, USP 2% | CLAY-PARK LABS, INC. | 11/7/2003 |
| 16 | 76-505 | METRONIDAZOLE CAPSULES 375 MG | ABLE LABORATORIES, INC. | 11/13/2003 |
| 17 | 76-481 | MOMETASONE FUROATE OINTMENT, USP 0.1% | ATRIX LABORATORIES, INC. | 11/14/2003 |
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