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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 088356

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NDA 088356 describes HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25, which is a drug marketed by Ivax Pharms and is included in one NDA. Additional details are available on the HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.

Summary for 088356

Tradename:	HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
Applicant:	Ivax Pharms
Ingredient:	hydralazine hydrochloride; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG;25MG
Approval Date:	Apr 10, 1984	TE:		RLD:	No

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