Last Updated: November 13, 2026

Details for New Drug Application (NDA): 080268

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NDA 080268 describes SULFISOXAZOLE, which is a drug marketed by Ani Pharms, Barr, Heather, Hikma, Impax Labs, Lannett, Lederle, Pharmeral, Purepac Pharm, Rising, Roxane, Valeant Pharm Intl, Vitarine, Watson Labs, and Sola Barnes Hind, and is included in fifteen NDAs. Additional details are available on the SULFISOXAZOLE profile page.

The generic ingredient in SULFISOXAZOLE is sulfisoxazole diolamine. There are two drug master file entries for this compound. Additional details are available on the sulfisoxazole diolamine profile page.

Summary for 080268

Tradename:	SULFISOXAZOLE
Applicant:	Valeant Pharm Intl
Ingredient:	sulfisoxazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 080268

Anti-Infective Agents

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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