Indomethacin

ANDA 70326, held by Duramed Pharms Barr. Indomethacin.

As of Nov 15, 2026, ANDA 70326 (Indomethacin), held by Duramed Pharms Barr, was first approved by FDA on Oct 18, 1985, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1985
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
Oct 18, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin25MG · capsule;oral	Indomethacin	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 17, 1991	Supplement 14Labeling	Approved	None posted
Feb 6, 1990	Supplement 11Labeling	Approved	None posted
Jun 1, 1989	Supplement 7Labeling	Approved	None posted
Jun 1, 1989	Supplement 8Labeling	Approved	None posted
Dec 19, 1988	Supplement 5Labeling	Approved	None posted
Oct 18, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70326
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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