Nitrofurazone

ANDA 86156, held by Sun Pharma Canada. Nitrofurazone.

As of Nov 14, 2026, ANDA 86156 (Nitrofurazone), held by Sun Pharma Canada, was first approved by FDA on Aug 15, 1978, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1978
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 15, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitrofurazone0.2% · ointment;topical	Nitrofurazone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Sep 14, 1992	Supplement 21Labeling	Approved	None posted
Jul 28, 1992	Supplement 20Labeling	Approved	None posted
Aug 18, 1989	Supplement 19Manufacturing	Approved	None posted
May 11, 1989	Supplement 17Manufacturing	Approved	None posted
May 11, 1989	Supplement 18Manufacturing	Approved	None posted
Feb 16, 1989	Supplement 16Labeling	Approved	None posted
Aug 8, 1986	Supplement 13Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 11Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1984	Supplement 8Manufacturing	Approved	None posted
Aug 25, 1982	Supplement 7Manufacturing	Approved	None posted
Jun 29, 1982	Supplement 6Manufacturing	Approved	None posted
Aug 15, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86156
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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