Indomethacin

ANDA 91276, held by Glenmark Pharms Ltd. Indomethacin.

As of Nov 15, 2026, ANDA 91276 (Indomethacin), held by Glenmark Pharms Ltd, was first approved by FDA on Dec 22, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2010
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 22, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Indomethacin25MG · capsule;oral	Indomethacin	Rx
Indomethacin50MG · capsule;oral	Indomethacin	Rx

All 6 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Feb 2, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Feb 2, 2020	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Dec 22, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91276
Drugs@FDA: Overview at FDA
Company: Glenmark 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