Mycophenolate Mofetil

ANDA 90419, held by Apotex Corp. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 90419 (Mycophenolate Mofetil), held by Apotex Corp, was first approved by FDA on Apr 22, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2009
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

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

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Nov 13, 2015	Supplement 9REMS	Approved	None posted
Oct 6, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Sep 27, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Sep 25, 2012	Supplement 4REMS	Approved	None posted
Aug 31, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Apr 16, 2010	Supplement 3Labeling	Approved	None posted
Apr 15, 2010	Supplement 2Labeling	Approved	None posted
Apr 22, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 90419
Drugs@FDA: Overview at FDA
Company: Apotex

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