Indomethacin

ANDA 200529, held by Chartwell Rx. Indomethacin.

As of Nov 15, 2026, ANDA 200529 (Indomethacin), held by Chartwell Rx, was first approved by FDA on Nov 30, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2010
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
Nov 30, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 5Labeling · Standard review	Approved	None posted
May 12, 2021	Supplement 4Labeling · Standard review	Approved	None posted
May 10, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Nov 30, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 200529
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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