Mycophenolate Mofetil

ANDA 90606, held by Amneal. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 90606 (Mycophenolate Mofetil), held by Amneal, was first approved by FDA on Jul 16, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2010
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 16, 2010	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycophenolate Mofetil500MG · tablet;oral	Mycophenolate Mofetil	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 19REMS	Approved	None posted
Aug 13, 2024	Supplement 15REMS	Approved	None posted
Aug 11, 2021	Supplement 11REMS	Approved	None posted
Apr 21, 2021	Supplement 10REMS	Approved	None posted
Jan 15, 2021	Supplement 9REMS	Approved	None posted
Jul 27, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 7REMS	Approved	None posted
Sep 27, 2013	Supplement 6REMS	Approved	None posted
Sep 25, 2012	Supplement 3REMS	Approved	None posted
Aug 1, 2012	Supplement 4Labeling · Standard review	Approved	None posted
Jul 16, 2010	Original application	Approved	Other

Identifiers

Application: ANDA 90606
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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