Mesalamine

ANDA 210509, held by Amneal. Mesalamine.

As of Nov 13, 2026, ANDA 210509 (Mesalamine), held by Amneal, was first approved by FDA on Jan 2, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 2, 2020
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 2, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mesalamine1GM · suppository;rectal	Mesalamine	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 12, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Aug 7, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Oct 28, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Oct 28, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Jan 2, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 210509
Drugs@FDA: Overview at FDA
Company: Amneal 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