|
| 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 |
