Application 076688

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;6.25MG	No	No
002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;12.5MG	No	No
003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;12.5MG	No	No
004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;25MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4725	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4725	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4735	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4735	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4745	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4745	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4775	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4775	Benazepril Hydrochloride and Hydrochlorothiazide	benazepril hydrochloride and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
8948	ORIG	2004-02-12