Indomethacin

ANDA 71635, held by Watson Labs. Indomethacin.

As of Nov 15, 2026, ANDA 71635 (Indomethacin), held by Watson Labs, was first approved by FDA on May 18, 1987, with 4 approved supplements and 0 published complete response letters.

First approved: May 18, 1987
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 18, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 4, 1992	Supplement 9Labeling	Approved	None posted
Jan 3, 1992	Supplement 8Labeling	Approved	None posted
Jun 8, 1989	Supplement 7Labeling	Approved	None posted
Feb 2, 1989	Supplement 6Labeling	Approved	None posted
May 18, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71635
Drugs@FDA: Overview at FDA
Company: Watson 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