Mycophenolate Mofetil

Prevents organ rejection. ANDA 200197, held by Alkem Labs Ltd. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 200197 (Mycophenolate Mofetil), held by Alkem Labs Ltd, was first approved by FDA on Jun 13, 2013, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2013
Supplements approved: 15
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 16 submissions below

Date	Submission	Status	Documents
Jun 13, 2013	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 32REMS	Approved	None posted
Aug 13, 2024	Supplement 27REMS	Approved	None posted
Jan 3, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 21REMS	Approved	None posted
Apr 21, 2021	Supplement 20REMS	Approved	None posted
Jan 15, 2021	Supplement 17REMS	Approved	None posted
Aug 12, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Sep 10, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 3REMS	Approved	None posted
Oct 5, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Jun 13, 2013	Original application	Approved	Other

Identifiers

Application: ANDA 200197
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