Mycophenolate Mofetil

ANDA 90111, held by Strides Pharma Intl. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 90111 (Mycophenolate Mofetil), held by Strides Pharma Intl, was first approved by FDA on Dec 22, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2009
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 22, 2009	Original application	Approved	Other

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 17REMS	Approved	None posted
Aug 13, 2024	Supplement 15REMS	Approved	None posted
Jun 6, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Jun 6, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 12REMS	Approved	None posted
Apr 21, 2021	Supplement 11REMS	Approved	None posted
Jan 15, 2021	Supplement 10REMS	Approved	None posted
Jul 27, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 8REMS	Approved	None posted
Sep 27, 2013	Supplement 7REMS	Approved	None posted
Sep 25, 2012	Supplement 4REMS	Approved	None posted
Aug 1, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Dec 22, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 90111
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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