Mycophenolate Mofetil

ANDA 204077, held by Zhejiang Hisun Pharm. Mycophenolate Mofetil.

As of Nov 14, 2026, ANDA 204077 (Mycophenolate Mofetil), held by Zhejiang Hisun Pharm, was first approved by FDA on Nov 13, 2017, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 13, 2017
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
Nov 13, 2017	Original application	Approved	REMS

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 8REMS	Approved	None posted
Aug 13, 2024	Supplement 7REMS	Approved	None posted
Jun 6, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jun 6, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Aug 11, 2021	Supplement 4REMS	Approved	None posted
Apr 21, 2021	Supplement 3REMS	Approved	None posted
Jan 15, 2021	Supplement 2REMS	Approved	None posted
Jun 19, 2019	Supplement 1Manufacturing	Approved	None posted
Nov 13, 2017	Original application	Approved	REMS

Identifiers

Application: ANDA 204077
Drugs@FDA: Overview at FDA
Company: Zhejiang Hisun Pharmaceutical

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