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: 2 brands, 2 generics; first approved Jun 05, 1998; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

SULFAMYLONRLD
MYLAN INSTITUTIONALNDA 0198321998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% FOR SOLUTION TOPICAL Discontinued -
SULFAMYLONRLDRS
RISINGNDA 016763-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 85MG BASE/GM CREAM TOPICAL Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	FOR SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 85MG BASE/GM	CREAM	TOPICAL	Rx	-

Generic (ANDA) products (2)

Abbreviated applications

MAFENIDE ACETATE
INGENUS PHARMS LLCANDA 2067162017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% FOR SOLUTION TOPICAL Discontinued -
MAFENIDE ACETATE
PH HEALTHANDA 2015112013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% FOR SOLUTION TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	FOR SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	FOR SOLUTION	TOPICAL	Discontinued	-

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Jun 05, 1998

28 yr 10 mo ago

Most recent approval

Jul 31, 2017

9 yr 4 mo ago

Approvals span 1998–2017 across 4 FDA applications.

Brand (NDA) 250%

Generic (ANDA) 250%

Mafenide acetate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Mafenide acetate

Key facts