Indomethacin

As of Nov 15, 2026, ANDA 71343 (Indomethacin), held by Teva, was first approved by FDA on Apr 18, 1988, with 13 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1988
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Apr 18, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Mar 17, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 22, 1996	Supplement 13Manufacturing	Approved	None posted
Aug 2, 1994	Supplement 11Manufacturing	Approved	None posted
Jul 18, 1994	Supplement 12Manufacturing	Approved	None posted
Mar 31, 1994	Supplement 10Manufacturing	Approved	None posted
May 12, 1992	Supplement 7Manufacturing	Approved	None posted
Dec 31, 1991	Supplement 8Labeling	Approved	None posted
Jul 15, 1991	Supplement 6Manufacturing	Approved	None posted
Jul 13, 1989	Supplement 4Manufacturing	Approved	None posted
Jul 13, 1989	Supplement 3Manufacturing	Approved	None posted
Jul 13, 1989	Supplement 2Labeling	Approved	None posted
Jul 13, 1989	Supplement 1Manufacturing	Approved	None posted
Feb 16, 1989	Supplement 5Labeling	Approved	None posted
Apr 18, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71343
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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