Tivorbex

NDA 204768, held by Genus. Indomethacin.

As of Nov 13, 2026, NDA 204768 (Tivorbex), held by Genus, was first approved by FDA on Feb 24, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2014
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 24, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Tivorbex20MG · capsule;oral	Indomethacin	DiscontinuedReference drug
Tivorbex40MG · capsule;oral	Indomethacin	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 8Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 26, 2019	Supplement 6Labeling · Standard review	Approved	Letter Label Medication Guide
May 9, 2016	Supplement 3Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Jul 15, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 24, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 204768
Drugs@FDA: Overview at FDA
Company: Genus 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