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Office Of Generic Drugs ANDAs Approvals - July 2000

1

 . 65-011 CEFOXITIN FOR INJECTION, AMERICAN PHARMACEUTICAL

7/3/00

USP 10 G/VIAL (PHARMACY PARTNERS, INC.

BULK PACKAGE)

2

 . 65-012 CEFOXITIN FOR INJECTION, AMERICAN PHARMACEUTICAL

7/3/00

USP 1 G (20 & 100 ML VIALS) 2 G PARTNERS, INC.

(20 & 100 ML VIALS)

3

 . 75-238 SOTALOL HYDROCHLORIDE WATSON LABORATORIES, INC.

7/13/00

TABLETS 80 MG 120 MG 160 MG

240 MG

4

 . 40-351 HYDROCORTISONE LOTION, ALTANA INC.

7/25/00

USP 2.5%

5

 . 40-307 HYDROCODONE BITARTRATE BARR LABORATORIES, INC.

7/26/00

AND ACETAMINOPHEN

TABLETS, USP 2.5 MG/500 MG

7.5 MG/500 MG 7.5 MG/650 MG 10

MG/650 MG

6

 . 40-308 HYDROCODONE BITARTRATE BARR LABORATORIES, INC.

7/26/00

AND ACETAMINOPHEN

TABLETS, USP 5 MG/500 MG 7.5

MG/750 MG

7

 . 40-309 HYDROCODONE BITARTRATE BARR LABORATORIES, INC.

7/26/00

AND ACETAMINOPHEN

TABLETS, USP 10 MG/500 MG

8

 . 40-400 HYDROCODONE BITARTRATE MALLINCKRODT, INC.

7/26/00

AND ACETAMINOPHEN

TABLETS, USP 10 MG/325 MG

9

 . 75-678 PEMOLINE TABLETS AMIDE PHARMACEUTICAL,

7/26/00

(CHEWABLE) 37.5 MG INC.

10

 . 74-881 IOPAMIDOL INJECTION, USP COOK IMAGING CORPORATION

7/28/00

41% 51% 61% 76%

11

 . 75-419 ETODOLAC CAPSULES, USP 200 TORPHARM

7/28/00

MG 300 MG
12 . 75-667 TERAZOSIN HYDROCHLORIDE INVAMED INC. 7/28/00

CAPSULES 1MG (BASE) 2MG

(BASE) 5MG (BASE) 10MG

(BASE)

13 . 75-665 ETODOLAC TEVA PHARMACEUTICALS, 7/31/00

EXTENDED-RELEASE TABLETS USA

500 MG 600 MG

14 . 75-696 ETODOLAC WHITNEY PHARMACEUTICALS, 7/31/00

EXTENDED-RELEASE TABLETS INC.

400 MG

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Last Updated: September 10, 200125 Apr 2006 08:52:33 -0400
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