Mycophenolate Mofetil

ANDA 218566, held by Neocubes Pharma. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 218566 (Mycophenolate Mofetil), held by Neocubes Pharma, was first approved by FDA on Jun 1, 2026, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 1, 2026
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 1, 2026	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 1REMS	Approved	None posted
Jun 1, 2026	Original application	Approved	None posted

Identifiers

Application: ANDA 218566
Drugs@FDA: Overview at FDA
Company: Neocubes Pharma

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