|
| ANDA Number
| Drug Name
| Applicant
| Approval Date
|
| 1 |
75-810 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) |
BARR LABORATORIES, INC. |
2/1/02 |
| 2 |
76-165 |
FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG |
RANBAXY LABORATORIES LIMITED |
2/1/02 |
| 3 |
40-321 |
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 20 MG |
PUREPAC PHARMACEUTICAL CO. |
2/5/02 |
| 4 |
40-428 |
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 25 MG |
G &W LABORATORIES, INC. |
2/5/02 |
| 5 |
76-097 |
CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 1% |
NOVEX PHARMA |
2/6/02 |
| 6 |
76-114 |
INDOMETHACIN EXTENDED-RELEASE CAPSULES, USP 75 MG |
ABLE LABORATORIES, INC. |
2/6/02 |
| 7 |
75-292 |
FLUOXETINE ORAL SOLUTION, USP 20 MG(BASE)/5 ML |
NOVEX PHARMA |
2/7/02 |
| 8 |
75-364 |
KETOPROFEN TABLETS 12.5 MG TABLETS AND CAPLETS |
L. PERRIGO COMPANY |
2/7/02 |
| 9 |
76-193 |
PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG |
KV PHARMACEUTICAL COMPANY |
2/7/02 |
| 10 |
40-422 |
AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL) AND 30 MG (TOTAL) |
BARR LABORATORIES, INC. |
2/11/02 |
| 11 |
75-281 |
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 50 MG, AND 75 MG |
ALPHAPHARM PTY. LTD. |
2/12/02 |
| 12 |
65-043 |
CEFUROXIME AXETIL TABLETS , USP 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE). |
RANBAXY LABORATORIES, LTD. |
2/15/02 |
| 13 |
75-997 |
MEGESTROL ACETATE ORAL SUSPENSION 40 MG/ML |
ROXANE LABORATORIES, INC. |
2/15/02 |
| 14 |
74-805 |
FLUNISOLIDE NASAL SOLUTION, USP 0.025% (25 MCG/SPRAY), 200 METERED SPRAY CONTAINER |
BAUSCH & LOMB PHARMACEUTICALS |
2/20/02 |
| 15 |
75-679 |
KETOPROFEN EXTENDED-RELEASE CAPSULES 100 MG, 150 MG, AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
2/20/02 |
| 16 |
76-175 |
MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
2/20/02 |
| 17 |
75-470 |
DICLOFENAC POTASSIUM TABLETS 50 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
2/21/02 |
| 18 |
75-911 |
LACTULOSE SOLUTION, USP 10 G/15 ML |
NOVEX PHARMA |
2/21/02 |
| 19 |
76-038 |
METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
2/21/02 |
| 20 |
65-087 |
TOBRAMYCIN OPHTHALMIC SOLUTION, USP 0.3% |
NOVEX PHARMA |
2/25/02 |
| 21 |
75-280 |
NABUMETONE TABLETS 500 MG 750 MG |
EON LABS MANUFACTURING, INC. |
2/25/02 |
| 22 |
75-590 |
NABUMETONE TABLETS 500 MG AND 750 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
2/25/02 |
| 23 |
75-874 |
IFOSFAMIDE INJECTION/MESNA INJECTION KIT 50 MG/ML (1 G/20 ML OR 3 G/60 ML), AND 100 MG/ML (1 G/10 ML), RESPECTIVELY |
GENSIA SICOR PHARMACEUTICALS, INC. |
2/26/02 |
| 24 |
65-022 |
BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINT, USP 500 UNITS/G AND 10,000 UNITS/G, RESPECTIVELY |
ALTANA INC. |
2/27/02 |
| 25 |
75-572 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG |
KV PHARMACEUTICAL CO. |
2/27/02 |
| 26 |
75-948 |
CARBAMAZEPINE TABLETS, USP 200 MG |
APOTEX INC. |
2/27/02 |
| 27 |
75-022 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG |
TEVA PHARMACEUTICALS USA |
2/28/02 |
| 28 |
75-865 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
2/28/02 |
