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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 089201

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NDA 089201 describes HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Solvay, Superpharm, and Watson Labs, and is included in eight NDAs. Additional details are available on the HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 089201

Tradename:	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Applicant:	Superpharm
Ingredient:	hydralazine hydrochloride; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG;50MG
Approval Date:	Feb 9, 1987	TE:		RLD:	No

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