Is there a generic for Sulfisoxazole diolamine?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Sulfisoxazole diolamine, referencing the brand GANTRISIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sulfisoxazole diolamine?

GANTRISIN (NDA 006917, ROCHE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sulfisoxazole diolamine are approved?

Sulfisoxazole diolamine is approved in the following dosage forms: injectable, ointment, solution/drops.

FDA Orange Book · active-ingredient family

Sulfisoxazole diolamine

Sulfisoxazole diolamine is approved as 3 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GANTRISIN · NDA 006917

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, ointment, solution/drops

Product	Applicant	Application	TE	Approved
GANTRISIN	ROCHE	NDA 006917	—	Approved Prior to Jan 1, 1982
GANTRISIN	ROCHE	NDA 008414	—	Approved Prior to Jan 1, 1982
GANTRISIN	ROCHE	NDA 007757	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
SULFISOXAZOLE DIOLAMINE	SOLA BARNES HIND	ANDA 084148	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Sulfisoxazole diolamine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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