Indomethacin

ANDA 202139, held by Mylan. Indomethacin.

As of Nov 15, 2026, ANDA 202139 (Indomethacin), held by Mylan, was first approved by FDA on Mar 20, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2014
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 20, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin75MG · capsule, extended release;oral	Indomethacin	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Sep 30, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Nov 21, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Apr 23, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Apr 23, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 20, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202139
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