Triple Sulfas

NDA 6920, held by Lederle. Trisulfapyrimidines (Sulfadiazine;Sulfamerazine;Sulfamethazine).

As of Nov 13, 2026, NDA 6920 (Triple Sulfas), held by Lederle, was first approved by FDA on Aug 16, 1949, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1949
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 16, 1949	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Triple Sulfas167MG;167MG;167MG · tablet;oral	Trisulfapyrimidines (Sulfadiazine;Sulfamerazine;Sulfamethazine)	Discontinued
Triple Sulfas167MG/5ML;167MG/5ML;167MG/5ML · suspension;oral	Trisulfapyrimidines (Sulfadiazine;Sulfamerazine;Sulfamethazine)	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 17, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 12, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 22, 1977	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 17, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 16, 1949	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 6920
Drugs@FDA: Overview at FDA
Company: Lederle Laboratories

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