Last Updated: June 9, 2026

Details for New Drug Application (NDA): 019358

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NDA 019358 describes AZO GANTRISIN, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the AZO GANTRISIN profile page.

The generic ingredient in AZO GANTRISIN is phenazopyridine hydrochloride; sulfisoxazole. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfisoxazole profile page.

Summary for 019358

Tradename:	AZO GANTRISIN
Applicant:	Roche
Ingredient:	phenazopyridine hydrochloride; sulfisoxazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 31, 1990	TE:		RLD:	Yes

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