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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076116

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NDA 076116 describes ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Anda Repository, Chartwell Rx, Cosette, Ivax Sub Teva Pharms, Mpp Pharma, Rising, and Taro Pharm Inds, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for 076116

Tradename:	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Applicant:	Chartwell Rx
Ingredient:	enalapril maleate; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;12.5MG
Approval Date:	Sep 19, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;25MG
Approval Date:	Sep 19, 2001	TE:		RLD:	No

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