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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 008414

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NDA 008414 describes GANTRISIN, which is a drug marketed by Roche and is included in five NDAs. Additional details are available on the GANTRISIN profile page.

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

Summary for 008414

Tradename:	GANTRISIN
Applicant:	Roche
Ingredient:	sulfisoxazole diolamine
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	EQ 4% BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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