Mycophenolate Mofetil

Prevents organ rejection. ANDA 65416, held by Accord Hlthcare. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 65416 (Mycophenolate Mofetil), held by Accord Hlthcare, was first approved by FDA on May 4, 2009, with 17 approved supplements and 0 published complete response letters.

First approved: May 4, 2009
Supplements approved: 17
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 18 submissions below

Date	Submission	Status	Documents
May 4, 2009	Original application	Approved	Other

Products

1 strengths and forms

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

All 18 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 28REMS	Approved	None posted
Aug 13, 2024	Supplement 25REMS	Approved	None posted
Aug 9, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Sep 18, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 21REMS	Approved	None posted
May 17, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Apr 21, 2021	Supplement 20REMS	Approved	None posted
Jan 15, 2021	Supplement 18REMS	Approved	None posted
Sep 11, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 11REMS	Approved	None posted
Nov 6, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Jun 1, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 9REMS	Approved	None posted
Sep 25, 2012	Supplement 6Labeling · Standard review	Approved	None posted
Aug 27, 2012	Supplement 7Labeling · Standard review	Approved	None posted
Nov 30, 2009	Supplement 3Labeling	Approved	None posted
Sep 8, 2009	Supplement 1Labeling	Approved	None posted
May 4, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 65416
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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