Is there a generic for Sulfanilamide?

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

What is the reference-listed drug for Sulfanilamide?

AVC (NDA 006530, PHARMOBEDIENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sulfanilamide are approved?

Sulfanilamide is approved in the following dosage forms: cream, suppository.

FDA Orange Book · active-ingredient family

Sulfanilamide

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

Reference-listed drug:AVC · NDA 006530

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, suppository

Product	Applicant	Application	TE	Approved
AVCRLD×2	PHARMOBEDIENT	NDA 006530	—	Jan 27, 1987

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
SULFANILAMIDE	COSETTE	ANDA 088718	—	Sep 19, 1985

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.

Sulfanilamide — frequently asked questions

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

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