| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
65-167 |
CYCLOSPORINE ORAL SOLUTION USP (MODIFIED)
100 MG/ML |
NOVEX PHARMA |
1/5/2005 |
| 2 |
76-813 |
ISOSORBIDE MONONITRATE EXTENDED-RELEASE
TABLETS 60 MG |
WEST-WARD PHARMACEUTICAL CORP. |
1/7/2005 |
| 3 |
77-218 |
POTASSIUM IODIDE ORAL SOLUTION, USP 65
MG/ML |
FLEMING & COMPANY, PHARMACEUTICALS |
1/12/2005 |
| 4 |
76-837 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE FLEXIBLE PLASTIC CONTAINERS |
SICOR PHARMACEUTICALS, INC. |
1/13/2005 |
| 5 |
76-049 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG
(BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
ANDRX PHARMACEUTICALS, INC. |
1/14/2005 |
| 6 |
77-095 |
METFORMIN HYDROCHLORIDE TABLETS 500 MG,
850 MG, AND 1 G |
AUROBINDO PHARMA LIMITED |
1/14/2005 |
| 7 |
76-043 |
TERCONAZOLE VAGINAL CREAM 0.4% |
TARO PHARMACEUTICALS USA, INC. |
1/19/2005 |
| 8 |
76-673 |
CIPROFLOXACIN OPHTHALMIC SOLUTION, USP
0.3% |
HI-TECH PHARMACAL CO., INC. |
1/21/2005 |
| 9 |
65-191 |
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
ORAL SUSPENSION, U 200 MG/28.5 MG(BASE) PER 5 ML AND 400
MG/57 MG (BASE) PER 5 ML |
HIKMA PHARMACEUTICALS |
1/25/2005 |
| 10 |
65-210 |
CLARITHROMYCIN EXTENDED-RELEASE TABLETS
1000 MG |
RANBAXY LABORATORIES LIMITED |
1/26/2005 |
| 11 |
76-144 |
MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG/ML
(SYRINGE) AND 5 MG/ML (SYRINGE) |
INTERNATIONAL MEDICATION SYSTEMS, LTD. |
1/26/2005 |
| 12 |
76-361 |
LEVOFLOXACIN TABLETS 750 MG |
TEVA PHARMACEUTICALS USA |
1/26/2005 |
| 13 |
76-703 |
DESMOPRESSIN ACETATE NASAL SOLUTION 0.01%
(NASAL SPRAY) |
APOTEX INC. |
1/27/2005 |
| 14 |
76-821 |
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG |
TEVA PHARMACEUTICALS USA |
1/27/2005 |
| 15 |
76-899 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLETS, USP 400 MG/80 MG AND 800 MG/160 MG (DOUBLE
STRENGTH) |
INTERPHARM, INC. |
1/27/2005 |
| 16 |
76-036 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG
(BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
PAR PHARMACEUTICAL, INC. |
1/28/2005 |
| 17 |
76-258 |
FENTANYL TRANSDERMAL SYSTEMS 25 MCG/HOUR,
50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR |
MYLAN TECHNOLOGIES, INC. |
1/28/2005 |
| 18 |
76-900 |
ATENOLOL TABLETS, USP 25 MG, 50 MG, AND
100 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
1/28/2005 |
| 19 |
40-530 |
TESTOSTERONE CYPIONATE INJECTION, USP 200
MG/ML; PACKAGED IN 1 ML AND 10 ML MULTIPLE-DOSE VIALS |
PADDOCK LABORATORIES |
1/31/2005 |
| 20 |
65-217 |
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
75 MG (BASE), 150 MG (BASE), AND 300 MG (BASE) |
ZYDUS PHARMACEUTICALS USA, INC. |
1/31/2005 |
