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Office Of Generic Drugs ANDAs Approvals - October 2000

Page: 1

1 . 40-304 OXYCODONE AND BARR LABORATORIES, INC. 10/2/00

ACETAMINOPHEN CAPSULES, USP

5 MG/500 MG


2 . 75-361 ISOSORBIDE MONONITRATE WESTWARD 10/5/00
TABLETS, 20 MG PHARMACEUTICAL CORP.


3 . 75-468 CLONAZEPAM TABLETS, USP TORPHARM 10/6/00

0.5 MG, 1 MG, 2 MG


4 . 75-613 BUPROPION HYDROCHLORIDE EON LABS MANUFACTURING, 10/10/00

TABLETS, 75 MG, 100 MG INC.


5 . 75-426 DOXAZOSIN MESYLATE CHELSEA LABORATORIES, INC. 10/18/00

TABLETS, 1 MG (BASE), 2 MG (BASE)

4 MG (BASE), 8 MG (BASE)


6 . 75-432 DOXASOZIN MESYLATE INVAMED INC. 10/18/00

TABLETS, 1 MG (BASE,) 2 MG (BASE)

4 MG (BASE), 8 MG (BASE)


7 . 75-453 DOXASOZIN MESYLATE ZENITH GOLDLINE 10/18/00

TABLETS, 1 MG (BASE), PHARMACEUTICALS, INC.

2 MG(BASE), 4 MG (BASE), 8 MG (BASE)


8 . 75-466 DOXASOZIN MESYLATE GENPHARM, INC. 10/18/00

TABLETS, 1 MG (BASE), 2 MG (BASE),

4 MG (BASE) 8 MG (BASE)


9 . 75-536 DOXAZOSIN MESYLATE TEVA PHARMACEUTICALS USA 10/18/00

TABLETS, 1 MG (BASE), 2 MG (BASE),

4 MG (BASE), 8 MG (BASE)


10 . 75-574 DOXAZOSIN MESYLATE PUREPAC PHARMACEUTICAL 10/18/00

TABLETS, 1 MG (BASE), CO.

2 MG (BASE), 4 MG (BASE), 8 MG  (BASE)


11 . 75-580 DOXAZOSIN MESYLATE TORPHARM 10/18/00

TABLETS, 1 MG (BASE), 2 MG (BASE),

4 MG (BASE), 8 MG (BASE)


12 . 75-609 DOXASOZIN MESYLATE KV PHARMACEUTICAL 10/18/00

TABLETS, 1 MG (BASE), COMPANY

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)


13 . 75-646 DOXAZOSIN MESYLATE EON LABS MANUFACTURING, 10/18/00

TABLETS,1 MG (BASE), INC.

2 MG (BASE), 4 MG (BASE), 8 MG (BASE)


14 . 75-509 DOXASOZIN MESYLATE MYLAN PHARMACEUTICALS, 10/19/00

TABLETS, 1 MG (BASE),  INC.

2 MG (BASE), 4 MG (BASE), 8 MG  (BASE)


15 . 75-641 MIDAZOLAM APOTHECON INC. 10/19/00

HYDROCHLORIDE INJECTION 

5 MG (BASE)/ML, (2 ML SYRINGE)


16 . 40-409 HYDROCODONE BITARTRATE MALLINCKRODT, INC. 10/20/00

AND ACETAMINOPHEN TABLETS, USP

5 MG/325 MG


17 . 75-203 PROPAFENONE WATSON LABORATORIES, INC. 10/24/00

HYDROCHLORIDE TABLETS,

150 MG, 225 MG


18 . 75-687 CARBAMAZEPINE TABLETS TARO PHARMACEUTICAL 10/24/00

USP,   (CHEWABLE) 100 MG INDUSTRIES, LTD.


19 . 75-471 LEUPROLIDE ACETATE GENSIA SICOR 10/25/00

INJECTION, 1 MG/0.2 MG PHARMACEUTICALS, INC.

(MULTIPLE-DOSE VIAL)


20 . 75-564 RANITIDINE CAPSULES,   GENPHARM INC. 10/27/00

150 MG, 300 MG


21 . 75-637 MIDAZOLAM APOTEX CORP. 10/31/00

HYDROCHLORIDE INJECTION,

1 MG (BASE)/ML,   5 MG (BASE)/ML

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FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:52:58 -0400
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