Mycophenolate Mofetil

ANDA 65457, held by Teva Pharms. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 65457 (Mycophenolate Mofetil), held by Teva Pharms, was first approved by FDA on May 4, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: May 4, 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
May 4, 2009	Original application	Approved	Other

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 19REMS	Approved	None posted
Aug 13, 2024	Supplement 18REMS	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 13, 2015	Supplement 9REMS	Approved	None posted
Oct 30, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 4REMS	Approved	None posted
Jul 25, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Feb 4, 2010	Supplement 2Labeling	Approved	None posted
Feb 2, 2010	Supplement 1Labeling	Approved	None posted
May 4, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 65457
Drugs@FDA: Overview at FDA
Company: Teva 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