| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-856 |
DANTROLENE SODIUM CAPSULES 25 MG, 50 MG, AND 100
MG |
IMPAX LABORATORTIES, INC. |
3/1/2005 |
| 2 |
76-943 |
TORSEMIDE TABLETS 5 MG, 10 MG, AND 20 MG |
ROXANE LABORATORIES, INC. |
3/1/2005 |
| 3 |
77-020 |
CILOSTAZOL TABLETS 100 MG |
IVAX PHARMACEUTICALS, INC. |
3/1/2005 |
| 4 |
65-200 |
GRISEOFULVIN ORAL SUSPENSION, USP 125 MG/5 ML |
STIEFEL LABORATORIES, INC. |
3/2/2005 |
| 5 |
74-777 |
RANITIDINE INJECTION, USP 25 MG/ML; PACKAGED IN
50 MG/2 ML VIALS |
BEN VENUE LABORATORIES, INC. |
3/2/2005 |
| 6 |
76-773 |
MICONAZOLE NITRATE VAGINAL CREAM (3-DAY
TREATMENT) (OTC) 4% |
TARO PHARMACEUTICALS U.S.A., INC. |
3/2/2005 |
| 7 |
76-803 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10
MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
EON LABS, INC. |
3/2/2005 |
| 8 |
76-931 |
BUPRENORPHINE HYDROCHLORIDE INJECTION 0.3 MG
(BASE)/ML |
BEDFORD LABORATORIES |
3/2/2005 |
| 9 |
77-146 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
WOCKHARDT LIMITED |
3/7/2005 |
| 10 |
65-195 |
CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG |
GENPHARM INC. |
3/11/2005 |
| 11 |
77-150 |
CILOSTAZOL TABLETS 50 MG |
COREPHARMA, LLC |
3/11/2005 |
| 12 |
75-400 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
L. PERRIGO COMPANY |
3/18/2005 |
| 13 |
76-959 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND
450 MG SINGLE-DOSE VIALS |
EON LABS, INC. |
3/18/2005 |
| 14 |
75-477 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG |
IVAX PHARMACEUTICALS, INC. |
3/23/2005 |
| 15 |
40-169 |
DICYCLOMINE HYDROCHLORIDE SYRUP, USP 10 MG/5 ML |
MIKART, INC. |
3/24/2005 |
| 16 |
65-078 |
CYCLOSPORINE ORAL SOLUTION, USP (MODIFIED) 100
MG/ML |
IVAX PHARMACEUTICALS S.R.O. |
3/25/2005 |
| 17 |
76-888 |
FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION)
2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE
PLASTIC CONTAINERS |
APOTEX CORP. |
3/25/2005 |
| 18 |
76-889 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE
INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML
SINGLE-DOSE PLASTIC CONTAINERS |
APOTEX CORP. |
3/25/2005 |
| 19 |
77-152 |
TERBUTALINE SULFATE TABLETS, USP 2.5 MG AND 5 MG
|
LANNETT HOLDINGS, INC. |
3/25/2005 |
| 20 |
76-313 |
OCTREOTIDE ACETATE INJECTION (PRESERVATIVE FREE)
0.05 MG/ML, 0.1 MG/ML, AND 0.5 MG/ML |
BEFORD LABORATORIES |
3/28/2005 |
| 21 |
77-061 |
MOMETASONE FUROATE OINTMENT, USP 0.1% |
ALTANA INC. |
3/28/2005 |
| 22 |
77-093 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TABLETS 10 MG (BASE)/12.5 MG, 20 MG (BASE)/12.5 MG, AND 20 MG
(BASE)/25 MG |
MYLAN PHARMACEUTICALS, INC. |
3/28/2005 |
| 23 |
65-110 |
CYCLOSPORINE CAPSULES USP (MODIFIED) 25 MG, 50
MG, AND 100 MG |
IVAX PHARMACEUTICALS S.R.O. |
3/29/2005 |
| 24 |
76-951 |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
CAPSULES 100 MG |
RANBAXY LABORATORIES LIMITED |
3/30/2005 |
