Indomethacin

ANDA 90403, held by Zydus Lifesciences. Indomethacin.

As of Nov 15, 2026, ANDA 90403 (Indomethacin), held by Zydus Lifesciences, was first approved by FDA on Nov 15, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 15, 2010
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 15, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Indomethacin25MG · capsule;oral	Indomethacin	Rx
Indomethacin50MG · capsule;oral	Indomethacin	Rx

All 7 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Mar 9, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2019	Supplement 5Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Nov 15, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90403
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

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