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Office Of Generic Drugs ANDAs Approvals- September 2000

Page: 1 Friday, October 06, 2000

1

 . 40-405 HYDROCODONE BITARTRATE MALLINCKRODT, INC.

9/8/00

AND ACETAMINOPHEN

TABLETS, USP 7.5 MG/325 MG


2

 . 75-411 TIMOLOL MALEATE NOVEX PHARMA

9/8/00

OPHTHALMIC SOLUTION, USP

0.25% (BASE)

3

 . 75-412 TIMOLOL MALEATE NOVEX PHARMA

9/8/00

OPHTHALMIC SOLUTION, USP

0.5% (BASE)

4

 . 65-050 CEFOXITIN FOR INJECTION, ESI LEDERLE

9/11/00

USP 10 G (PHARMACY BULK

PACKAGE)

5

 . 65-051 CEFOXITIN FOR INJECTION, ESI LEDERLE

9/11/00

USP 1 G 2 G

6

 . 75-184 PACLITAXEL INJECTION 6 BAKER NORTON

9/15/00

MG/ML PHARMACEUTICALS, INC.

7

 . 65-056 AMOXICILLIN TABLETS, USP TEVA PHARMACEUTICALS USA

9/18/00

500 MG 875 MG

8

 . 75-287 PEMOLINE TABLETS 37.5 MG 75 WATSON LABORATOTIES, INC.

9/18/00

MG

9

 . 75-392 PROPOFOL INJECTABLE GENSIA SICOR

9/19/00

EMULSION 1% (10 MG/ML) PHARMACEUTICALS, INC.

(SYRINGE)

10

 . 40-397 CARISOPRODOL TABLETS, USP COREPHARMA LLC

9/21/00

350 MG

11

 . 75-469 BISOPROLOL FUMARATE AND CHELSEA LABORATORIES, INC.

9/25/00

HYDROCHLOROTHIAZIDE

TABLETS 2.5 MG/6.25 MG 5

MG/6.25 MG 10 MG/6.25 MG

12

 . 75-527 BISOPROLOL FUMARATE AND INVAMED INC.

9/25/00

HYDROCHLOROTHIAZIDE

TABLETS 2.5 MG/6.25 MG 5

MG/6.25 MG 10 MG/6.25 MG

13 . 75-579 BISOPROLOL FUMARATE AND EON LABS MANUFACTURING, 9/25/00

HYDROCHLOROTHIAZIDE INC.

TABLETS 2.5 MG/6.25 MG 5

MG/6.25 MG 10 MG/6.25 MG

14 . 75-672 BISOPROLOL FUMARATE AND PUREPAC PHARMACEUTICAL 9/25/00

HYDROCHLOROTHIAZIDE CO.

TABLETS 2.5 MG/6.25 MG 5

MG/6.25 MG 10 MG/6.25 MG

15 . 75-768 BISOPROLOL FUMARATE AND MYLAN PHARMACEUTICALS, 9/25/00

HYDROCHLOROTHIAZIDE INC.

TABLETS 2.5 MG/6.5 MG 5

MG/6.25 MG 10 MG/6.5 MG

16 . 75-289 NIFEDIPINE BIOVAIL LABORATORIES, INC. 9/27/00

EXTENDED-RELEASE TABLETS,

USP 60 MG

17 . 75-632 BISOPROLOL FUMARATE AND ZENITH GOLDLINE 9/27/00

HYDROCHLOROTHIAZIDE PHARMACEUTICALS, INC.

TABLETS 2.5 MG/6.25 MG 5

MG/6.25 MG 10 MG/6.25 MG

18 . 75-446 BETAXOLOL OPHTHALMIC NOVEX PHARMA 9/28/00

SOLUTION, USP 0.5%

19 . 40-314 TROPICAMIDE OPHTHALMIC AKORN, INC. 9/29/00

SOLUTION, USP 0.5%

20 . 40-315 TROPICAMIDE OPHTHALMIC AKORN, INC. 9/29/00

SOLUTION, USP 1%

21 . 75-103 HYDROCODONE BITRATRATE ALPHARMA, U.S. 9/29/00

AND PHARMACEUTICALS DIV.

PHENYLPROPANOLAMINE HCL

SYRUP 5 MG/5 ML; 25 MG/5 ML

 

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