| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
40-453 |
DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML
PACKAGED IN 1 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
6/9/2003 |
| 2 |
75-992 |
VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML;
PACKAGED IN 10 MG (BASE)/1 ML & 50 MG (BASE)/5 ML SINGLE-DOSE
VIALS |
ESI LEDERLE |
6/10/2003 |
| 3 |
76-497 |
LOPERAMIDE HYDROCHLORIDE TABLETS, USP (OTC) 2 MG |
LNK INTERNATIONAL, INC. |
6/10/2003 |
| 4 |
76-270 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
ROXANE LABORATORIES, INC. |
6/19/2003 |
| 5 |
76-122 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
MYLAN PHARMACEUTICALS, INC. |
6/19/2003 |
| 6 |
76-189 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
GENEVA PHARMACEUTICALS, INC. |
6/19/2003 |
| 7 |
76-219 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
EON LABS, INC. |
6/19/2003 |
| 8 |
76-312 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
WATSON LABORATORIES, INC. |
6/19/2003 |
| 9 |
76-176 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
ALPHAPHARM PTY. LTD. |
6/19/2003 |
| 10 |
76-428 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN
20 MG (BASE)/20 ML SINGLE-USE VIALS |
BIONICHE (CANADA) LTD. |
6/16/2003 |
| 11 |
76-490 |
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 450 MG
|
WEST-WARD PHARMACEUTICAL CORP. |
6/17/2003 |
| 12 |
75-880 |
AMINO ACID INJECTION (SULFITE-FREE) (PREMASOL
INJECTION) 6% (500 ML) AND 10% (1000 & 2000 ML) VIAFLEX PLASTIC
CONTAINERS |
BAXTER HEALTHCARE CORPORATION |
6/19/2003 |
| 13 |
76-336 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
ANDRX PHARMACEUTICALS, LLC |
6/20/2003 |
| 14 |
76-308 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
PUREPAC PHARMACEUTICAL CO. |
6/20/2003 |
| 15 |
76-503 |
ISOTRETINOIN CAPSULES, USP 30 MG |
RANBAXY LABORATORIES LIMITED |
6/20/2003 |
| 16 |
76-411 |
METHENAMINE HIPPURATE TABLETS, USP 1 GRAM |
COREPHARMA LLC |
6/20/2003 |
| 17 |
40-435 |
EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MG |
BARR LABORATORIES, INC. |
6/20/2003 |
| 18 |
40-479 |
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG
AND 25 MG |
PADDOCK LABORATORIES, INC. |
6/24/2003 |
| 19 |
76-462 |
METRONIDAZOLE EXTENDED-RELEASE TABLETS 750 MG |
ABLE LABORATORIES, INC. |
6/25/2003 |
| 20 |
76-241 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
AMIDE PHARMACEUTICAL, INC. |
6/25/2003 |
| 21 |
76-539 |
VALPROATE SODIUM INJECTION 100 MG/ML |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
6/26/2003 |
| 22 |
75-798 |
ALLOPURINOL TABLETS, USP 100 MG AND 300 MG |
VINTAGE PHARMACEUTICALS, INC. |
6/27/2003 |
| 23 |
76-457 |
GANCICLOVIR CAPSULES 250 MG AND 500 MG |
RANBAXY LABORATORIES LTD. |
6/27/2003 |
| 24 |
76-519 |
METRONIDAZOLE TABLETS, USP 250 MG AND 500 MG |
ABLE LABORATORIES, INC. |
6/27/2003 |
| 25 |
40-500 |
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG
AND 25 MG |
CLAY-PARK LABS, INC. |
6/30/2003 |
| 26 |
40-465 |
DICYCLOMINE HYDROCHLORIDE INJECTION, USP
(PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS
|
BEDFORD LABORATORIES, INC. |
6/30/2003 |
