Mycophenolate Mofetil

Prevents organ rejection. ANDA 203005, held by Alkem Labs Ltd. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 203005 (Mycophenolate Mofetil), held by Alkem Labs Ltd, was first approved by FDA on Nov 14, 2014, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2014
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Nov 14, 2014	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycophenolate Mofetil200MG/ML · for suspension;oral	Mycophenolate Mofetil	Rx

All 14 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 23REMS	Approved	None posted
Aug 13, 2024	Supplement 20REMS	Approved	None posted
May 8, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Mar 8, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 17REMS	Approved	None posted
Apr 21, 2021	Supplement 16REMS	Approved	None posted
Jan 15, 2021	Supplement 13REMS	Approved	None posted
Nov 25, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jan 11, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jan 11, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jan 11, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 1REMS	Approved	None posted
Nov 6, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 14, 2014	Original application	Approved	Other

Identifiers

Application: ANDA 203005
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