Mycophenolate Mofetil

Prevents organ rejection. ANDA 65491, held by Teva Pharms. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 65491 (Mycophenolate Mofetil), held by Teva Pharms, was first approved by FDA on May 6, 2009, with 15 approved supplements and 0 published complete response letters.

First approved: May 6, 2009
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mycophenolate mofetil capsules (MMF) are 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 capsules are 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 16 submissions below

Date	Submission	Status	Documents
May 6, 2009	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycophenolate Mofetil250MG · capsule;oral	Mycophenolate Mofetil	Rx

All 16 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 34REMS	Approved	None posted
Aug 13, 2024	Supplement 30REMS	Approved	None posted
Aug 11, 2021	Supplement 23REMS	Approved	None posted
Apr 21, 2021	Supplement 22REMS	Approved	None posted
Jan 15, 2021	Supplement 21REMS	Approved	None posted
Aug 4, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 9REMS	Approved	None posted
Oct 30, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 6REMS	Approved	None posted
Jul 25, 2012	Supplement 7Labeling · Standard review	Approved	None posted
Feb 4, 2010	Supplement 5Labeling	Approved	None posted
Feb 2, 2010	Supplement 4Labeling	Approved	None posted
May 6, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 65491
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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