Sulfanilamide

ANDA 88718, held by Cosette Pharms Nc. Sulfanilamide.

As of Nov 14, 2026, ANDA 88718 (Sulfanilamide), held by Cosette Pharms Nc, was first approved by FDA on Sep 19, 1985, with 27 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1985
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Sep 19, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfanilamide15% · cream;vaginal	Sulfanilamide	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 33Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 32Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 28Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 24Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 27Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 26Manufacturing	Approved	None posted
Nov 2, 1994	Supplement 25Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 23Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 22Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 21Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 20Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 19Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 18Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 16Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 15Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 14Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 17Manufacturing	Approved	None posted
May 25, 1993	Supplement 13Manufacturing	Approved	None posted
May 25, 1993	Supplement 12Manufacturing	Approved	None posted
May 25, 1993	Supplement 11Manufacturing	Approved	None posted
May 21, 1993	Supplement 8Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 10Manufacturing	Approved	None posted
Feb 5, 1991	Supplement 7Labeling	Approved	None posted
Feb 6, 1990	Supplement 6Labeling	Approved	None posted
Feb 6, 1990	Supplement 4Labeling	Approved	None posted
Sep 5, 1989	Supplement 5Labeling	Approved	None posted
Jun 21, 1989	Supplement 3Manufacturing	Approved	None posted
Sep 19, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88718
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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