Furacin

As of Nov 14, 2026, NDA 5795 (Furacin), held by Shire, was first approved by FDA on Oct 4, 1945, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 4, 1945
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 4, 1945	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furacin0.2% · ointment;topical	Nitrofurazone	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 9, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 21, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 21, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 9, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 12, 1984	Supplement 7Labeling · Standard review	Approved	None posted
May 26, 1982	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 17, 1982	Supplement 6Labeling · Standard review	Approved	None posted
Sep 12, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 11, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 12, 1978	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 4, 1945	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 5795
Drugs@FDA: Overview at FDA
Company: Shire

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