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Office Of Generic Drugs ANDAs Approvals
August 2000

1

 . 75-473 LEVOBUNOLOL NOVEX PHARMA

8/3/00

HYDROCHLORIDE

OPHTHALMIC SOLUTION, USP

0.25%

2

 . 75-475 LEVOBUNOLOL NOVEX PHARMA

8/3/00

HYDROCHLORIDE

OPHTHALMIC SOLUTION, USP

0.5%

3

 . 75-048 ENALAPRIL MALEATE GENEVA PHARMACEUTICALS,

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 INC.

MG 20 MG

4

 . 75-369 ENALAPRIL MALEATE KRKA, d.d., NOVO MESTO

8/22/00

TABLETS, USP 10 MG 20 MG

5

 . 75-370 ENALAPRIL MALEATE KRKA, d.d., NOVO MESTO

8/22/00

TABLETS, USP 2.5 MG 5 MG

6

 . 75-456 ENALAPRILAT INJECTION 1.25 ABBOTT LABORATORIES

8/22/00

MG/ML (SYRINGE)

7

 . 75-458 ENALAPRILAT INJECTION 1.25 ABBOTT LABORATORIES

8/22/00

MG/ML (VIALS)

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

MG 20 MG

10

 . 75-479 ENALAPRIL MALEATE TEVA PHARMACEUTICALS,

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 USA

MG 20 MG

11

 . 75-480 ENALAPRIL MALEATE MYLAN PHARMACEUTICALS,

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 INC.

MG 20 MG

12

 . 75-482 ENALAPRIL MALEATE ZENITH GOLDLINE

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 PHARMACEUTICALS, INC.


MG 20 MG

13

 . 75-483 ENALAPRIL MALEATE WOCKHARDT AMERICAS, INC.

8/22/00

TABLETS, USP 2.5 MG 5 MG 10

MG 20 MG

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

MG 20 MG

16

 . 75-556 ENALAPRIL MALEATE RANBAXY LABORATORIES

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 LIMITED

MG 20 MG

17

 . 75-571 ENALAPRILAT INJECTION 1.25 FAULDING PHARMACEUTICAL

8/22/00

MG/ML (VIALS) CO.

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

MG 20 MG

20

 . 75-621 ENALAPRIL MALEATE EON LABS MANUFACTURING,

8/22/00

TABLETS, USP 2.5 MG 5 MG 10 INC.

MG 20 MG

21

 . 75-634 ENALAPRILAT INJECTION 1.25 BEDFORD LABORATORIES

8/22/00

MG/ML (VIALS)

22

 . 75-606 NORTRIPTYLINE PHARMACEUTICAL

8/23/00

HYDROCHLORIDE ORAL ASSOCIATES, INC.

SOLUTION, USP 10 MG

(BASE)/ML

23

 . 75-220 DESMOPRESSIN ACETATE ABBOTT LABORATORIES

8/28/00

INJECTION 4 mcg/mL

24

 . 75-734 HYDROXYUREA TABLETS 1 G BARR LABORATORIES, INC.

8/29/00


25

 . 75-792 PROPRANOLOL BEDFORD LABORATORIES

8/29/00

HYDROCHLORIDE INJECTION,

USP 1 MG/ML

 

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