Mycophenolate Mofetil

Prevents organ rejection. ANDA 65413, held by Hikma. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 65413 (Mycophenolate Mofetil), held by Hikma, was first approved by FDA on Jul 29, 2008, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2008
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jul 29, 2008	Original application	Approved	Other Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycophenolate Mofetil500MG · tablet;oral	Mycophenolate Mofetil	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 26REMS	Approved	None posted
Aug 13, 2024	Supplement 24REMS	Approved	None posted
Feb 7, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Feb 7, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Feb 7, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 20REMS	Approved	None posted
May 17, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Apr 21, 2021	Supplement 18REMS	Approved	None posted
Jan 15, 2021	Supplement 15REMS	Approved	None posted
Jun 16, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 10REMS	Approved	None posted
Oct 30, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Sep 12, 2014	Supplement 6Manufacturing	Approved	None posted
Sep 27, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 8REMS	Approved	None posted
Jul 25, 2012	Supplement 7Labeling · Standard review	Approved	None posted
Feb 2, 2010	Supplement 4Labeling	Approved	None posted
Sep 9, 2009	Supplement 3Labeling	Approved	None posted
Feb 20, 2009	Supplement 2Labeling	Approved	None posted
Jul 29, 2008	Original application	Approved	Other Label Letter

Identifiers

Application: ANDA 65413
Drugs@FDA: Overview at FDA
Company: Hikma

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