| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
65-036 |
IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS) |
GENSIA SICOR PHARMACEUTICALS, INC. |
5/1/02 |
| 2 |
65-037 |
IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
5/1/02 |
| 3 |
75-774 |
AMMONIUM LACTATE CREAM 12% (BASE) |
CLAY-PARK LABS, INC. |
5/1/02 |
| 4 |
75-594 |
PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL 90 MG/VIAL |
AESGEN, INC. |
5/6/02 |
| 5 |
75-773 |
PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL AND 90 MG/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/6/02 |
| 6 |
76-131 |
PACLITAXEL INJECTION 6 MG/ML (PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS) |
ABBOTT LABORATORIES |
5/8/02 |
| 7 |
65-040 |
CYCLOSPORINE CAPSULES, USP 25 MG AND 100 MG |
TORPHARM |
5/9/02 |
| 8 |
75-388 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG |
PHARMEX PRODUCTS, INC. |
5/9/02 |
| 9 |
75-846 |
OXAPROZIN TABLETS 600 MG |
IVAX PHARMACEUTICALS, INC. |
5/13/02 |
| 10 |
76-110 |
TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MG |
TEVA PHARMACEUTICALS USA |
5/14/02 |
| 11 |
76-207 |
PAMIDRONATE DISODIUM INJECTION 3 MG/ML (PACKAGED IN 30 MG/10 ML SINGLE-USE VIALS), AND 9 MG/ML (PACKAGED IN 90 MG/10 ML SINGLE-USE VIALS) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/17/02 |
| 12 |
65-010 |
NEOMYCIN SULFATE ORAL SOLUTION, USP 125 MG/5 ML |
PHARMA-TEK, INC. |
5/23/02 |
| 13 |
75-866 |
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG; PACKAGED IN 21-DAY (PORTIA-21) AND 28-DAY (PORTIA-28) CYCLES |
BARR LABORATORIES, INC. |
5/23/02 |
| 14 |
40-466 |
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50 MG/ML, (1 ML FILL IN 2 ML SINGLE- DOSE VIAL). |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/28/02 |
| 15 |
75-510 |
MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML; 100 ML SINGLE-DOSE VIAL FOR INFUSION |
ESI LEDERLE |
5/28/02 |
| 16 |
75-530 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 MG (BASE)/10 ML & 20 MG (BASE)/20 ML SINGLE-DOSE VIALS |
ESI LEDERLE |
5/28/02 |
| 17 |
75-660 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
5/28/02 |
| 18 |
75-830 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 ML, 20 ML, AND 50 ML VIALS |
FAULDING PHARMACEUTICAL CO. |
5/28/02 |
| 19 |
75-834 |
MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML, PACKAGED IN 100 ML AND 200 ML SINGLE-DOSE PLASTIC CONTAINERS FOR INTRAVENOUS INFUSION |
BAXTER HEALTHCARE CORPORATION |
5/28/02 |
| 20 |
75-852 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALS |
BAXTER HEALTHCARE CORPORATION |
5/28/02 |
| 21 |
75-884 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALS |
ABBOTT LABORATORIES |
5/28/02 |
| 22 |
75-885 |
MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML, PACKAGED IN 100 ML AND 200 ML SINGLE-DOSE FLEXIBLE CONTAINERS |
ABBOTT LABORATORIES |
5/28/02 |
| 23 |
75-936 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/28/02 |
| 24 |
76-078 |
IFOSFAMIDE FOR INJECTION, USP 1 G AND 3 G SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/28/02 |
| 25 |
75-586 |
METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.4% (10 MG/2.5 ML) AND 0.6% (15 MG/2.5 ML) UNIT-DOSE VIALS |
MORTON GROVE PHARMACEUTICALS, INC. |
5/30/02 |
| 26 |
65-082 |
CEFPODOXIME PROXETIL FOR ORAL SUSPENSION 50 MG (BASE)/5 ML AND 100 MG (BASE)/5 ML |
RANBAXY LABORATORIES LIMITED |
5/31/02 |
| 27 |
76-229 |
AMCINONIDE CREAM, USP 0.1% |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
5/31/02 |
