Indomethacin

ANDA 204853, held by Novast Labs. Indomethacin.

As of Nov 15, 2026, ANDA 204853 (Indomethacin), held by Novast Labs, was first approved by FDA on May 8, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: May 8, 2017
Review: Standard
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 8, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin75MG · capsule, extended release;oral	Indomethacin	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 2Labeling · Standard review	Approved	None posted
May 8, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204853
Drugs@FDA: Overview at FDA
Company: Novast 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