Thermazene

Treats wound sepsis. NDA 18810, held by Thepharmanetwork LLC. Silver Sulfadiazine.

As of Nov 13, 2026, NDA 18810 (Thermazene), held by Thepharmanetwork LLC, was first approved by FDA on Dec 23, 1985, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1985
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Silver sulfadiazine cream, USP 1% 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 13 submissions below

Date	Submission	Status	Documents
Dec 23, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thermazene1% · cream;topical	Silver Sulfadiazine	Rx

All 13 submissions, including labeling and manufacturing supplements


Aug 11, 2016	Supplement 20Manufacturing	Approved	None posted
Nov 27, 2012	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 27, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 7, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
May 10, 1990	Supplement 8Labeling	Approved	None posted
Oct 24, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 12, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 17, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 17, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 4, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 23, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18810
Drugs@FDA: Overview at FDA
Company: THEPHARMANETWORK LLC

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