Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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