Sulfadiazine, Sulfadiazine Sodium

NDA 4054, held by Lederle. Sulfadiazine, Sulfadiazine Sodium.

As of Nov 14, 2026, NDA 4054 (Sulfadiazine, Sulfadiazine Sodium), held by Lederle, was first approved by FDA on Aug 11, 1941, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1941
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 11, 1941	Original application	Approved	None posted

Products

2 strengths and forms


Sulfadiazine500MG · tablet;oral	Sulfadiazine	Discontinued
Sulfadiazine Sodium250MG/ML · injectable;injection	Sulfadiazine Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 14, 1985	Supplement 8Manufacturing	Approved	None posted
Jan 17, 1980	Supplement 7Manufacturing	Approved	None posted
Jun 13, 1978	Supplement 6Manufacturing	Approved	None posted
Jan 23, 1978	Supplement 5Manufacturing	Approved	None posted
Apr 20, 1977	Supplement 1	Approved	None posted
Aug 11, 1941	Original application	Approved	None posted

Identifiers

Application: NDA 4054
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