Application 075579

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	2.5MG;6.25MG	No	No
002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;6.25MG	No	No
003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;6.25MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0707	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Eon Labs, Inc.	ANDA	Current
0185-0707	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Eon Labs, Inc.	ANDA	Current
21695-808	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
21695-809	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
63629-4072	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
8723	ORIG	2004-05-28
8722	ORIG	2000-09-25