Mycophenolate Mofetil

ANDA 90762, held by Jubilant Cadista. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 90762 (Mycophenolate Mofetil), held by Jubilant Cadista, was first approved by FDA on Dec 15, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2014
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 15, 2014	Original application	Approved	Other

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 12REMS	Approved	None posted
Aug 13, 2024	Supplement 11REMS	Approved	None posted
Aug 11, 2021	Supplement 10REMS	Approved	None posted
Apr 21, 2021	Supplement 9REMS	Approved	None posted
Jan 15, 2021	Supplement 6REMS	Approved	None posted
Jul 27, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 2REMS	Approved	None posted
Dec 15, 2014	Original application	Approved	Other

Identifiers

Application: ANDA 90762
Drugs@FDA: Overview at FDA
Company: Jubilant Cadista 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