Drug Information |
ANDA Number | Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 75-743 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | PAR PHARMACEUTICAL, INC. | 7/1/02 |
2 | 75-752 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | IVAX PHARMACEUTICALS, INC. | 7/1/02 |
3 | 75-776 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/ 25 MG | IVAX PHARMACEUTICALS, INC. | 7/1/02 |
4 | 75-783 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | TEVA PHARMACEUTICALS USA | 7/1/02 |
5 | 75-869 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | TEVA PHARMACEUTICALS USA | 7/1/02 |
6 | 75-903 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | GENEVA PHARMACEUTICALS TECHNOLOGY CORPOR | 7/1/02 |
7 | 75-926 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | GENEVA PHARMACEUTICALS TECHNOLOGY CORP. | 7/1/02 |
8 | 75-944 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MG | RANBAXY LABORATORIES, LTD. | 7/1/02 |
9 | 75-982 | TRAMADOL HYDROCHLORIDE TABLETS 50 MG | SIDMAK LABORATORIES, INC. | 7/1/02 |
10 | 75-994 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | EON LABS, INC. | 7/1/02 |
11 | 75-999 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | LEK PHARMACEUTICAL AND CHEMICAL COMPANY | 7/1/02 |
12 | 76-007 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | RANBAXY LABORATORIES LIMITED | 7/1/02 |
13 | 76-059 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | WATSON LABORATORIES, INC. | 7/1/02 |
14 | 76-063 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MG | WEST-WARD PHARMACEUTICAL CORP. | 7/1/02 |
15 | 76-071 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG | MYLAN PHARMACEUTICALS, INC. | 7/1/02 |
16 | 76-113 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | MYLAN PHARMACEUTICALS, INC. | 7/1/02 |
17 | 76-164 | LISINOPRIL TABLETS, USP 20 MG, 30 MG, AND 40 MG | PUREPAC PHARMACEUTICAL CO. | 7/1/02 |
18 | 76-180 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, AND 10 MG | PUREPAC PHARMACEUTICAL CO. | 7/1/02 |
19 | 76-194 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | WATSON LABORATORIES, INC. | 7/1/02 |
20 | 76-230 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | PUREPAC PHARMACEUTICAL CO. | 7/1/02 |
21 | 76-262 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | EON LABS INC. | 7/1/02 |
22 | 75-895 | SEVOFLURANE LIQUID FOR INHALATION 100 % | BAXTER HEALTHCARE CORPORATION | 7/2/02 |
23 | 75-849 | OXAPROZIN TABLETS 600 MG | TEVA PHARMACEUTICALS USA | 7/3/02 |
24 | 75-963 | TRAMADOL HYDROCHLORIDE TABLETS 50 MG | ABLE LABORATORIES, INC. | 7/3/02 |
25 | 76-284 | TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE), AND 4 MG (BASE) | TEVA PHARMACEUTICALS USA | 7/3/02 |
26 | 76-286 | TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE), AND 4 MG (BASE) | DR. REDDY'S LABORATORIES, LTD. | 7/3/02 |
27 | 75-806 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | MYLAN PHARMACEUTICALS, INC. | 7/5/02 |
28 | 76-051 | LABETALOL HYDROCHLORIDE INJECTION, USP 5 MG/ML, PACKAGED IN 20 MG/4 ML AND 40 MG/8 ML SINGLE-USE VIALS; AND 100 MG/20 ML AND 200 MG/40 ML MULTIPLE-DOSE VIALS | APOTEX CORP. | 7/5/02 |
29 | 76-178 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | EON LABS MANUFACTURING, INC. | 7/5/02 |
30 | 75-461 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | ZENITH GOLDLINE PHARMACEUTICALS, INC. | 7/8/02 |
31 | 75-953 | CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG | DR. REDDY'S LABORATORIES, LTD. | 7/8/02 |
32 | 76-265 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG | WEST-WARD PHARMACEUTICAL CORP. | 7/8/02 |
33 | 40-437 | EDETATE DISODIUM INJECTION, USP 150 MG/ML (3 G/20 ML SINGLE-DOSE VIALS) | BIONICHE PHARMA (CANADA) LTD. | 7/9/02 |
34 | 75-616 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | WATSON LABORATORIES, INC. | 7/9/02 |
35 | 75-934 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | GENPHARM INC. | 7/9/02 |
36 | 75-981 | TRAMADOL HYDROCHLORIDE TABLETS 50 MG | TORPHARM | 7/10/02 |
37 | 76-095 | MISOPROSTOL TABLETS 0.1 MG AND 0.2 MG | IVAX PHARMACEUTICALS, INC. | 7/10/02 |
38 | 40-256 | PREDNISONE TABLETS, USP 5 MG, AND 10 MG | VINTAGE PHARMACEUTICALS, INC. | 7/12/02 |
39 | 75-250 | PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 ML | WE PHARMACEUTICALS, INC. | 7/12/02 |
40 | 75-974 | TRAMADOL HYDROCHLORIDE TABLETS 50 MG | ASTA MEDICA, INC. | 7/12/02 |
41 | 76-283 | TIZANIDINE HYDROCHLORIDE TABLETS 4 MG (BASE) | PUREPAC PHARMACEUTICAL CO. | 7/12/02 |
42 | 75-857 | MIDAZOLAM HYDROCHLORIDE INJECTION (PRESERVATIVE-FREE) 1 MG (BASE)/ML PACKAGED IN 2 MG (BASE)/ 2 ML AND 5 MG (BASE)/ 5 ML SINGLE-DOSE VIALS; AND 5 MG (BASE)/ML PACKAGED IN 5 MG (BASE)/1 ML AND 10 MG (BASE)/2 ML SINGLE-DOSE VIALS | ABBOTT LABORATORIES | 7/22/02 |
43 | 75-867 | IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% (PACKAGED IN 2.5 ML UNIT DOSE VIALS) | ROXANE LABORATORIES, INC. | 7/22/02 |
44 | 75-943 | ETODOLAC EXTENDED-RELEASE TABLETS 400 MG, 500 MG, AND 600 MG | EON LABS, INC. | 7/26/02 |
45 | 76-268 | DIGOXIN TABLETS, USP 0.125 MG AND 0.25 MG | JEROME STEVENS PHARMACEUTICALS, INC. | 7/26/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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