Mycophenolate Mofetil

Prevents organ rejection. ANDA 90055, held by Strides Pharma. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 90055 (Mycophenolate Mofetil), held by Strides Pharma, was first approved by FDA on Jun 10, 2010, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 10, 2010
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Jun 10, 2010	Original application	Approved	Other

Products

1 strengths and forms

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

All 17 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 46REMS	Approved	None posted
Feb 12, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Feb 12, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Feb 12, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Feb 12, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Aug 13, 2024	Supplement 33REMS	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 4, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Aug 1, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 5REMS	Approved	None posted
Sep 27, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 2REMS	Approved	None posted
Aug 29, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jun 10, 2010	Original application	Approved	Other

Identifiers

Application: ANDA 90055
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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