Furoxone

As of Nov 13, 2026, NDA 11270 (Furoxone), held by Shire, was first approved by FDA on Mar 21, 1961, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 21, 1961
Review: Standard
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
Mar 21, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furoxone100MG · tablet;oral	Furazolidone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 15, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 15, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 13, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 20, 1986	Supplement 16Labeling · Standard review	Approved	None posted
Jun 18, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 21, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11270
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