Details for New Drug Application (NDA): 084811

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NDA 084811 describes APRESAZIDE, which is a drug marketed by Novartis and is included in three NDAs. Additional details are available on the APRESAZIDE profile page.

The generic ingredient in APRESAZIDE 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 084811

Tradename:	APRESAZIDE
Applicant:	Novartis
Ingredient:	hydralazine hydrochloride; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG;50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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