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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078848

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NDA 078848 describes BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Corepharma, Genpharm, Heritage Pharma, Prinston Inc, Rising, Sun Pharm Inds Ltd, Teva, Zydus Lifesciences, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, and Sandoz, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the BENAZEPRIL HYDROCHLORIDE profile page.

The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

Summary for 078848

Tradename:	BENAZEPRIL HYDROCHLORIDE
Applicant:	Zydus Lifesciences
Ingredient:	benazepril hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 23, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 23, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 23, 2008	TE:	AB	RLD:	No

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