Mesalamine

ANDA 202065, held by Sandoz. Mesalamine.

As of Nov 13, 2026, ANDA 202065 (Mesalamine), held by Sandoz, was first approved by FDA on Jun 12, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 12, 2019
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
Jun 12, 2019	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mesalamine1GM · suppository;rectal	Mesalamine	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 31, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Sep 7, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Sep 7, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Nov 30, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Jun 12, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 202065
Drugs@FDA: Overview at FDA
Company: Sandoz

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