Indomethacin

NDA 18730, held by Ivax Sub Teva Pharms. Indomethacin.

As of Nov 13, 2026, NDA 18730 (Indomethacin), held by Ivax Sub Teva Pharms, was first approved by FDA on May 4, 1984, with 2 approved supplements and 0 published complete response letters.

First approved: May 4, 1984
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 4, 1984	Original application	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Indomethacin25MG · capsule;oral	Indomethacin	Discontinued
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 24, 1989	Supplement 18Manufacturing	Approved	None posted
Oct 4, 1985	Supplement 2Manufacturing	Approved	None posted
May 4, 1984	Original application	Approved	Review

Identifiers

Application: NDA 18730
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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