Mesalamine

ANDA 203574, held by Mylan. Mesalamine.

As of Nov 13, 2026, ANDA 203574 (Mesalamine), held by Mylan, was first approved by FDA on Nov 20, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 20, 2018
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
Nov 20, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mesalamine1.2GM · tablet, delayed release;oral	Mesalamine	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 20, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Nov 20, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 203574
Drugs@FDA: Overview at FDA
Company: Mylan

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