Indomethacin

ANDA 202706, held by Jubilant Generics. Indomethacin.

As of Nov 15, 2026, ANDA 202706 (Indomethacin), held by Jubilant Generics, was first approved by FDA on Oct 5, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 5, 2015
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
Oct 5, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Apr 19, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Jun 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Oct 5, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202706
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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