Mycophenolate Sodium

ANDA 214289, held by Twi Pharms. Mycophenolate Sodium.

As of Nov 15, 2026, ANDA 214289 (Mycophenolate Sodium), held by Twi Pharms, was first approved by FDA on Nov 3, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 3, 2021
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
Nov 3, 2021	Original application	Approved	REMS

Products

2 strengths and forms


Mycophenolate SodiumEQ 180MG BASE · tablet, delayed release;oral	Mycophenolate Sodium	Discontinued
Mycophenolate SodiumEQ 360MG BASE · tablet, delayed release;oral	Mycophenolate Sodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 9REMS	Approved	None posted
Aug 13, 2024	Supplement 7REMS	Approved	None posted
Jan 31, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Nov 3, 2021	Original application	Approved	REMS

Identifiers

Application: ANDA 214289
Drugs@FDA: Overview at FDA
Company: TWi 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