|
Office
Of Generic Drugs ANDAs Approvals
August 2000 |
|
1 |
. |
75-473 |
LEVOBUNOLOL |
NOVEX PHARMA |
8/3/00 |
|
2 |
. |
75-475 |
LEVOBUNOLOL |
NOVEX PHARMA |
8/3/00 |
|
3 |
. |
75-048 |
ENALAPRIL MALEATE |
GENEVA PHARMACEUTICALS, |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
INC. |
|
4 |
. |
75-369 |
ENALAPRIL MALEATE |
KRKA, d.d., NOVO MESTO |
8/22/00 |
|
5 |
. |
75-370 |
ENALAPRIL MALEATE |
KRKA, d.d., NOVO MESTO |
8/22/00 |
|
6 |
. |
75-456 |
ENALAPRILAT INJECTION 1.25 |
ABBOTT LABORATORIES |
8/22/00 |
|
7 |
. |
75-458 |
ENALAPRILAT INJECTION 1.25 |
ABBOTT LABORATORIES |
8/22/00 |
|
8 |
. |
75-459 |
ENALAPRIL MALEATE |
LEK PHARMACEUTICAL AND |
8/22/00 |
|
TABLETS USP 10 MG 20 MG |
CHEMICAL CO. d.d. |
|
9 |
. |
75-472 |
ENALAPRIL MALEATE |
GENPHARM INC. |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
|
10 |
. |
75-479 |
ENALAPRIL MALEATE |
TEVA PHARMACEUTICALS, |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
USA |
|
11 |
. |
75-480 |
ENALAPRIL MALEATE |
MYLAN PHARMACEUTICALS, |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
INC. |
|
12 |
. |
75-482 |
ENALAPRIL MALEATE |
ZENITH GOLDLINE |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
PHARMACEUTICALS, INC. |
|
13 |
. |
75-483 |
ENALAPRIL MALEATE |
WOCKHARDT AMERICAS, INC. |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
|
14 |
. |
75-496 |
ENALAPRIL MALEATE |
LEK PHARMACEUTICAL AND |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG |
CHEMICAL CO. d.d. |
|
15 |
. |
75-501 |
ENALAPRIL MALEATE |
CHELSEA LABORATORIES, INC. |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
|
16 |
. |
75-556 |
ENALAPRIL MALEATE |
RANBAXY LABORATORIES |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
LIMITED |
|
17 |
. |
75-571 |
ENALAPRILAT INJECTION 1.25 |
FAULDING PHARMACEUTICAL |
8/22/00 |
|
18 |
. |
75-578 |
ENALAPRILAT INJECTION 1.25 |
GENSIA SICOR |
8/22/00 |
|
MG/ML (VIALS) |
PHARMACEUTICALS, INC. |
|
19 |
. |
75-583 |
ENALAPRIL MALEATE |
APOTHECON, INC. |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
|
20 |
. |
75-621 |
ENALAPRIL MALEATE |
EON LABS MANUFACTURING, |
8/22/00 |
|
TABLETS, USP 2.5 MG 5 MG 10 |
INC. |
|
21 |
. |
75-634 |
ENALAPRILAT INJECTION 1.25 |
BEDFORD LABORATORIES |
8/22/00 |
|
22 |
. |
75-606 |
NORTRIPTYLINE |
PHARMACEUTICAL |
8/23/00 |
|
HYDROCHLORIDE ORAL |
ASSOCIATES, INC. |
|
23 |
. |
75-220 |
DESMOPRESSIN ACETATE |
ABBOTT LABORATORIES |
8/28/00 |
|
24 |
. |
75-734 |
HYDROXYUREA TABLETS 1 G |
BARR LABORATORIES, INC. |
8/29/00 |
|
25 |
. |
75-792 |
PROPRANOLOL |
BEDFORD LABORATORIES |
8/29/00 |
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FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:52:42 -0400
Originator: OGD
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