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Office Of Generic Drugs ANDAs Approvals
May 2000
 

1 . 75-237 SOTALOL HYDROCHLORIDE GENPHARM INC. 5/1/00

TABLETS 80 MG 120 MG 160 MG

240 MG

2 . 75-366 SOTALOL HYDROCHLORIDE EON LABS MANUFACTURING, 5/1/00

TABLETS 80 MG 120 MG 160 MG INC.

240 MG

3 . 75-429 SOTALOL HYDROCHLORIDE TEVA PHARMACEUTICALS USA 5/1/00

TABLETS 80 MG 120 MG 160 MG

240 MG

4 . 40-357 DIPHENOXYLATE HCL & PAR PHARMACEUTICAL, INC. 5/2/00

ATROPINE SULFATE TABLETS,

USP 2.5 MG/0.025 MG

5 . 40-378 NIACIN TABLETS, USP 500 MG UPSHER-SMITH 5/3/00

LABORATORIES, INC.

6 . 75-167 RANITIDINE TABLETS, USP TORPHARM INC. 5/4/00

(OTC) 75 MG

7 . 75-520 NORTRIPTYLINE TARO PHARMACEUTICAL 5/8/00

HYDROCHLORIDE CAPSULES, INDUSTRIES, LTD.

USP 10 MG (BASE) 25 MG (BASE)

50 MG (BASE) 75 MG (BASE)

8 . 75-513 AMRINONE INJECTION, USP 5 BEDFORD LABORATORIES 5/9/00

MG/ML (20 ML SINGLE-DOSE

VIAL)

9 . 75-629 METHYLPHENIDATE MALLINCKRODT, INC. 5/9/00

HYDROCHLORIDE

EXTENDED-RELEASE TABLETS,

USP 10 MG 20 MG

10 . 75-542 AMRINONE INJECTION, USP 5 BAXTER PHARMACEUTICAL 5/10/00

MG/ML (20 ML SINGLE-DOSE PRODUCTS, INC.

VIAL)

11 . 65-003 CYCLOSPORINE CAPSULES, USP ABBOTT LABORATORIES 5/12/00

(MODIFIED) 25 MG 50 MG 100

MG

12 . 74-656 CISPLATIN INJECTION 1 MG/ PHARMACHEMIE B.V. 5/16/00

ML

13 . 74-814 CISPLATIN INJECTION 1 MG/ML GENSIA SICOR 5/16/00

PHARMACEUTICALS, INC.

14 . 75-633 CLOBETASOL PROPIONATE TARO PHARMACEUTICALS 5/17/00

CREAM, USP (EMOLLIENT) U.S.A., INC.

0.05%

15 . 74-446 TERAZOSIN HYDROCHLORIDE NOVOPHARM LIMITED 5/18/00

TABLETS 1 MG (BASE) 2 MG

(BASE) 5 MG (BASE) 10 MG

(BASE)

16 . 75-666 HYDROCORTISONE VALERATE CLAY-PARK LABS, INC. 5/24/00

CREAM, USP 0.2%

17 . 65-049 CLINDAMYCIN PHOSPHATE CLAY-PARK LABS, INC. 5/25/00

TOPICAL SOLUTION, USP

(SWABS/PLEDGETS) 1% (BASE)


18 . 75-592 URSODIOL CAPSULES, USP 300 COPLEY PHARMACEUTICAL, 5/25/00

MG INC.

19 . 75-189 NABUMETONE TABLETS 500 TEVA PHARMACEUTICALS USA 5/26/00

MG

20 . 40-355 HYDROCODONE BITARTRATE VINTAGE PHARMACEUTICALS, 5/31/00

& ACETAMINOPHEN TABLETS, INC.

USP 10 MG/325 MG

21 . 40-356 HYDROCODONE BITARTRATE VINTAGE PHARMACEUTICALS, 5/31/00

& ACETAMINOPHEN TABLETS, INC.

USP 10 MG/500 MG

22 . 40-358 HYDROCODONE BITARTRATE VINTAGE PHARMACEUTICALS, 5/31/00

& ACETAMINOPHEN TABLETS, INC.

USP 10 MG/660 MG

23 . 74-539 TAMOXIFEN CITRATE PHARMACHEMIE B.V. 5/31/00

TABLETS, USP 10 MG (BASE)


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