Furadantin

NDA 8693, held by Procter And Gamble. Nitrofurantoin.

As of Nov 13, 2026, NDA 8693 (Furadantin), held by Procter And Gamble, was first approved by FDA on Feb 6, 1953, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 6, 1953
Review: Priority
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 18, 1993	Supplement 20Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 6, 1953	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Furadantin50MG · tablet;oral	Nitrofurantoin	Discontinued
Furadantin100MG · tablet;oral	Nitrofurantoin	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 17, 1998	Supplement 28Labeling · Priority review	Approved	None posted
Feb 17, 1998	Supplement 26Labeling · Priority review	Approved	None posted
Jul 16, 1997	Supplement 30Labeling · Priority review	Approved	None posted
Mar 27, 1997	Supplement 29Labeling · Priority review	Approved	None posted
Aug 9, 1993	Supplement 27Manufacturing · Priority review	Approved	None posted
May 18, 1993	Supplement 20Efficacy (new indication or use) · Priority review	Approved	None posted
May 13, 1988	Supplement 25Labeling · Priority review	Approved	Review
Jul 14, 1983	Supplement 21Manufacturing · Priority review	Approved	None posted
Nov 18, 1982	Supplement 19Labeling · Priority review	Approved	None posted
Dec 17, 1979	Supplement 16Labeling · Priority review	Approved	None posted
Jun 29, 1979	Supplement 17Manufacturing · Priority review	Approved	None posted
Mar 16, 1979	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 30, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
May 11, 1976	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 6, 1953	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 8693
Drugs@FDA: Overview at FDA
Company: Procter & Gamble

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