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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076739

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NDA 076739 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, and Teva, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for 076739

Tradename:	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	fosinopril sodium; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;12.5MG
Approval Date:	Dec 17, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG;12.5MG
Approval Date:	Dec 17, 2004	TE:		RLD:	No

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