Indomethacin

ANDA 202572, held by Watson Labs Inc. Indomethacin.

As of Nov 15, 2026, ANDA 202572 (Indomethacin), held by Watson Labs Inc, was first approved by FDA on Dec 9, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 9, 2013
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 9, 2013	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 9, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202572
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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