Mycophenolate Mofetil

Prevents organ rejection. ANDA 91249, held by Alkem Labs Ltd. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 91249 (Mycophenolate Mofetil), held by Alkem Labs Ltd, was first approved by FDA on Nov 4, 2011, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2011
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
Nov 4, 2011	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 34REMS	Approved	None posted
Aug 13, 2024	Supplement 30REMS	Approved	None posted
Jan 3, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 26Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 24REMS	Approved	None posted
Apr 21, 2021	Supplement 23REMS	Approved	None posted
Jan 15, 2021	Supplement 20REMS	Approved	None posted
Aug 12, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 6REMS	Approved	None posted
Oct 6, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Aug 9, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Nov 4, 2011	Original application	Approved	Other

Identifiers

Application: ANDA 91249
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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