Imuran

NDA 17391, held by Casper Pharma LLC. Azathioprine Sodium.

As of Nov 13, 2026, NDA 17391 (Imuran), held by Casper Pharma LLC, was first approved by FDA on Jul 19, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 19, 1974
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
Jul 19, 1974	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ImuranEQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Azathioprine Sodium	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 9, 2024	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 20, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 6, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
May 24, 2011	Supplement 15Labeling	Approved	Letter Label
Jul 9, 2008	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 26, 2005	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 19, 2002	Supplement 11Labeling · Standard review	Approved	Letter
Sep 26, 1997	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 9, 1994	Supplement 10Manufacturing · Priority review	Approved	None posted
Aug 30, 1994	Supplement 3Labeling	Approved	None posted
Sep 2, 1993	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 23, 1992	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 23, 1982	Supplement 2Labeling	Approved	None posted
Sep 20, 1978	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 19, 1974	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 17391
Drugs@FDA: Overview at FDA
Company: Casper Pharma

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