Imuran

Prevents rejection in renal homotransplantation. NDA 16324, held by Legacy. Azathioprine.

As of Nov 14, 2026, NDA 16324 (Imuran), held by Legacy, was first approved by FDA on Mar 20, 1968, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 20, 1968
Review: Priority
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Apr 13, 1981	Supplement 10Efficacy (new indication or use)	Approved	None posted
Mar 20, 1968	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Imuran50MG · tablet;oral	Azathioprine	RxReference drug
Imuran25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Azathioprine	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Jul 9, 2024	Supplement 40Labeling · Standard review	Approved	Label Letter
Dec 20, 2018	Supplement 39Labeling · Standard review	Approved	Letter Label
Nov 22, 2017	Supplement 38Manufacturing · Standard review	Approved	Letter
May 21, 2014	Supplement 36Manufacturing · Priority review	Approved	None posted
Feb 6, 2014	Supplement 37Labeling · Standard review	Approved	Letter Label
May 24, 2011	Supplement 34Labeling	Approved	Letter Label
May 24, 2011	Supplement 35Labeling	Approved	Letter Label
Jul 9, 2008	Supplement 31Labeling · Standard review	Approved	Letter Label
Jul 26, 2005	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 19, 2002	Supplement 26Labeling · Standard review	Approved	Letter
Aug 30, 1994	Supplement 11Labeling	Approved	None posted
Oct 26, 1992	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 9, 1992	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 28, 1992	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 17, 1989	Supplement 16Manufacturing · Priority review	Approved	None posted
May 24, 1988	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 18, 1988	Supplement 17Manufacturing · Priority review	Approved	None posted
Feb 26, 1987	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 13, 1981	Supplement 10Efficacy (new indication or use)	Approved	None posted
Mar 21, 1980	Supplement 8Manufacturing · Priority review	Approved	None posted
Jun 7, 1978	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 20, 1968	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16324
Drugs@FDA: Overview at FDA
Company: LEGACY

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