Mycophenolate Mofetil

ANDA 211272, held by Teva Pharms USA. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 211272 (Mycophenolate Mofetil), held by Teva Pharms USA, was first approved by FDA on Jan 25, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jan 25, 2022	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycophenolate Mofetil200MG/ML · for suspension;oral	Mycophenolate Mofetil	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 4REMS	Approved	None posted
Oct 17, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Aug 13, 2024	Supplement 3REMS	Approved	None posted
Jan 25, 2022	Original application	Approved	REMS

Identifiers

Application: ANDA 211272
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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