Ivadantin

NDA 12402, held by Procter And Gamble. Nitrofurantoin Sodium.

As of Nov 13, 2026, NDA 12402 (Ivadantin), held by Procter And Gamble, was first approved by FDA on Sep 15, 1960, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1960
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
Sep 15, 1960	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
IvadantinEQ 180MG BASE/VIAL · injectable;injection	Nitrofurantoin Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 18, 1982	Supplement 19Labeling · Standard review	Approved	None posted
Apr 13, 1982	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 13, 1979	Supplement 17Labeling · Standard review	Approved	None posted
Jun 6, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 6, 1979	Supplement 16Labeling · Standard review	Approved	None posted
Sep 15, 1960	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 12402
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