Mycophenolate Mofetil

Prevents organ rejection. ANDA 65451, held by Sandoz. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 65451 (Mycophenolate Mofetil), held by Sandoz, was first approved by FDA on Oct 15, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2008
Supplements approved: 18
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 19 submissions below

Date	Submission	Status	Documents
Oct 15, 2008	Original application	Approved	Other

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 43REMS	Approved	None posted
Aug 13, 2024	Supplement 38REMS	Approved	None posted
Jan 30, 2023	Supplement 33Labeling · Standard review	Approved	None posted
Jan 30, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Mar 8, 2022	Supplement 32Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 30REMS	Approved	None posted
May 17, 2021	Supplement 26Labeling · Standard review	Approved	None posted
Apr 21, 2021	Supplement 28REMS	Approved	None posted
Jan 15, 2021	Supplement 27REMS	Approved	None posted
Sep 11, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Sep 11, 2019	Supplement 25Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 18REMS	Approved	None posted
Nov 9, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 16Labeling · Standard review	Approved	None posted
Oct 12, 2012	Supplement 10Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 9REMS	Approved	None posted
Feb 2, 2010	Supplement 3Labeling	Approved	None posted
Mar 24, 2009	Supplement 1Labeling	Approved	None posted
Oct 15, 2008	Original application	Approved	Other

Identifiers

Application: ANDA 65451
Drugs@FDA: Overview at FDA
Company: Sandoz

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