Sulfamylon

NDA 19832, held by Mylan Institutional. Mafenide Acetate.

As of Nov 13, 2026, NDA 19832 (Sulfamylon), held by Mylan Institutional, was first approved by FDA on Jun 5, 1998, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1998
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 5, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfamylon5% · for solution;topical	Mafenide Acetate	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Jan 20, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 18, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 18, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
May 9, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 17, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 12, 2001	Supplement 3Manufacturing · Standard review	Approved	Letter
Jul 12, 2001	Supplement 2Labeling · Standard review	Approved	Letter
Sep 25, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 5, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 19832
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters