Sultrin

NDA 5794, held by Ortho Mcneil Pharm. Triple Sulfa (Sulfabenzamide;Sulfacetamide;Sulfathiazole).

As of Nov 14, 2026, NDA 5794 (Sultrin), held by Ortho Mcneil Pharm, was first approved by FDA on Sep 12, 1945, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1945
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 12, 1945	Original application	Approved	None posted

Products

2 strengths and forms


Sultrin3.7%;2.86%;3.42% · cream;vaginal	Triple Sulfa (Sulfabenzamide;Sulfacetamide;Sulfathiazole)	Discontinued
Sultrin184MG;143.75MG;172.5MG · tablet;vaginal	Triple Sulfa (Sulfabenzamide;Sulfacetamide;Sulfathiazole)	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 15, 2000	Supplement 24Manufacturing	Approved	None posted
Nov 1, 1999	Supplement 23Manufacturing	Approved	None posted
Sep 12, 1996	Supplement 22Manufacturing	Approved	None posted
Jul 1, 1992	Supplement 20Manufacturing	Approved	None posted
Jun 25, 1992	Supplement 21Manufacturing	Approved	None posted
Nov 22, 1991	Supplement 18Labeling	Approved	None posted
Sep 12, 1945	Original application	Approved	None posted

Identifiers

Application: NDA 5794
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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