Ssd, Ssd Af

Treats wound sepsis. NDA 18578, held by Dr Reddys. Silver Sulfadiazine.

As of Nov 14, 2026, NDA 18578 (Ssd, Ssd Af), held by Dr Reddys, was first approved by FDA on Feb 25, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1982
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 25, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Ssd1% · cream;topical	Silver Sulfadiazine	RxReference drug
Ssd Af1% · cream;topical	Silver Sulfadiazine	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 21, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
May 24, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 12, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 11, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 3, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 11, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 11, 1990	Supplement 6Labeling	Approved	None posted
Mar 15, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 10, 1985	Supplement 5Labeling	Approved	None posted
Jan 29, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 16, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 19, 1983	Supplement 3Labeling	Approved	None posted
May 12, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 25, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18578
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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