Indomethacin

ANDA 70068, held by Mutual Pharm. Indomethacin.

As of Nov 15, 2026, ANDA 70068 (Indomethacin), held by Mutual Pharm, was first approved by FDA on Oct 3, 1986, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1986
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 3, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 14Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 13Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 9Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 11Manufacturing	Approved	None posted
Jul 2, 1991	Supplement 8Labeling	Approved	None posted
Jun 7, 1989	Supplement 6Labeling	Approved	None posted
Feb 2, 1989	Supplement 5Labeling	Approved	None posted
Mar 24, 1988	Supplement 4Labeling	Approved	None posted
Nov 27, 1987	Supplement 3Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 1Manufacturing	Approved	None posted
Oct 3, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70068
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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