Indomethacin

ANDA 72410, held by Inwood Labs. Indomethacin.

As of Nov 15, 2026, ANDA 72410 (Indomethacin), held by Inwood Labs, was first approved by FDA on Mar 15, 1989, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 15, 1989
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 15, 1989	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Apr 15, 1998	Supplement 12Manufacturing	Approved	None posted
Nov 28, 1995	Supplement 11Manufacturing	Approved	None posted
Jul 28, 1995	Supplement 2Manufacturing	Approved	None posted
Aug 5, 1993	Supplement 8Labeling	Approved	None posted
Apr 2, 1993	Supplement 7Labeling	Approved	None posted
Dec 9, 1992	Supplement 6Labeling	Approved	None posted
Nov 9, 1992	Supplement 5Manufacturing	Approved	None posted
Apr 17, 1992	Supplement 4Labeling	Approved	None posted
Apr 15, 1991	Supplement 1Manufacturing	Approved	None posted
Mar 15, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72410
Drugs@FDA: Overview at FDA
Company: Inwood 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