Is there a generic for Mafenide acetate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Mafenide acetate, referencing the brand SULFAMYLON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mafenide acetate?

SULFAMYLON (NDA 019832, MYLAN INSTITUTIONAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mafenide acetate are approved?

Mafenide acetate is approved in the following dosage forms: cream, for solution.

FDA Orange Book · active-ingredient family

Mafenide acetate

Mafenide acetate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SULFAMYLON · NDA 019832

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, for solution

Product	Applicant	Application	TE	Approved
SULFAMYLONRLD	MYLAN INSTITUTIONAL	NDA 019832	—	Jun 05, 1998
SULFAMYLONRLD	RISING	NDA 016763	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
MAFENIDE ACETATE	INGENUS PHARMS LLC	ANDA 206716	—	Jul 31, 2017
MAFENIDE ACETATE	PH HEALTH	ANDA 201511	—	Feb 12, 2013

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.

Mafenide acetate — frequently asked questions

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

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