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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 088357

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NDA 088357 describes HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50, which is a drug marketed by Ivax Pharms and is included in one NDA. Additional details are available on the HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 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 088357

Tradename:	HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
Applicant:	Ivax Pharms
Ingredient:	hydralazine hydrochloride; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG;50MG
Approval Date:	Apr 10, 1984	TE:		RLD:	No

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