U.S. Food and Drug Administration • Center for Drug Evaluation and Research
CDER - Center for Drug Evaluation and Research Logo

Drug Information

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

Office Of Generic Drugs ANDAs Approvals-November 2000

Page: 1

1 . 75-620 MIDAZOLAM APOTHECON INC. 11/1/00

HYDROCHLORIDE INJECTION

1 MG (BASE)/ML,    5 MG (BASE)/ML


2 . 75-036 CISPLATIN INJECTION 1 MG/ML BEDFORD LABORATORIES 11/7/00


3 . 75-663 SOTALOL HYDROCHLORIDE IMPAX LABORATORIES, INC. 11/7/00

TABLETS 80 MG, 120 MG, 160 MG

240 MG

4 . 74-713 CISPLATIN FOR INJECTION USP, BEDFORD LABORATORIES 11/14/00

10 MG/VIAL 50 MG/VIAL

5 . 75-561 CHLORHEXIDINE GLUCONATE NOVEX PHARMA 11/14/00

ORAL RINSE 0.12%

6 . 40-379 FLUOROURACIL INJECTION, BIGMAR, INC. 11/15/00

USP 50 MG/ML (100 ML

PHARMACY BULK PACKAGE)


7 . 75-643 BISOPROLOL FUMARATE EON LABS MANUFACTURING, 11/16/00

TABLETS 5 MG, 10 MG INC.

8 . 75-518 MINOXIDIL TOPICAL ALPHARMA 11/17/00

SOLUTION, USP (FOR MEN) 5%


9 . 75-619 MINOXIDIL TOPICAL COPLEY PHARMACEUTICAL, 11/17/00

SOLUTION, USP (FOR MEN) 5% INC.


10 . 40-253 ETHOSUXIMIDE SYRUP PHARMACEUTICAL 11/22/00

250 MG/5 ML ASSOCIATES, INC.

11 . 65-053 DOXYCYCLINE CAPSULES, USP RANBAXY LABORATORIES 11/22/00

50 MG, 100 MG LIMITED

12 . 65-059 AMOXICILLIN TABLETS, USP RANBAXY LABORATORIES 11/24/00

500 MG, 875 MG LIMITED

13 . 40-395 DIPHENOXYLATE ABLE LABORATORIES, INC. 11/27/00

HYDROCHLORIDE AND

ATROPINE SULFATE TABLETS USP,

2.5 MG/0.025 MG

14 . 75-703 CLEMASTINE FUMARATE NOVEX PHARMA 11/27/00

SYRUP,  0.5 MG (BASE)/5 ML

15 . 75-348 KETOROLAC TROMETHAMINE APOTHECON, INC. 11/28/00

INJECTION USP,   15 MG/ML

(SYRINGE),  30 MG/ML (SYRINGE)


16 . 65-060 AMOXICILLIN TABLETS, USP RANBAXY LABORATORIES 11/29/00

(CHEWABLE) 200 MG, 400 MG LIMITED

17 . 75-742 RANITIDINE HYDROCHLORIDE CHEMINOR DRUGS LIMITED 11/29/00

CAPSULES,  150 MG (BASE),

300 MG (BASE)

18 . 75-888 FLUVOXAMINE MALEATE EON LABS MANUFACTURING, 11/29/00

TABLETS, 25 MG, 50 MG, 100 MG INC.


19 . 75-889 FLUVOXAMINE MALEATE MYLAN PHARMACEUTICALS, 11/29/00

TABLETS, 25 MG, 50 MG,. 100 MG INC.


20 . 65-062 MINOCYCLINE RANBAXY PHARMACEUTICALS 11/30/00

HYDROCHLORIDE CAPSULES INC.

USP,  50 MG, 75 MG, 100 MG

 

totop.gif (1525 bytes) Back to Top   Back Back to Approvals

FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:53:06 -0400
Originator: OGD
HTML by  PKS