Fortesta

NDA 21463, held by Endo Operations. Testosterone.

As of Nov 14, 2026, NDA 21463 (Fortesta), held by Endo Operations, was first approved by FDA on Dec 29, 2010, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2010
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 29, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fortesta10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel, metered;transdermal	Testosterone	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 30, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 13, 2020	Supplement 22Labeling · Standard review	Approved	Letter Label
May 30, 2019	Supplement 21REMS	Approved	Letter
May 10, 2019	Supplement 20Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 10, 2016	Supplement 18Manufacturing · Standard review	Approved	Label
May 11, 2015	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 31, 2014	Supplement 15REMS	Approved	Letter
Jun 19, 2014	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 4, 2014	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 24, 2014	Supplement 12Labeling · Standard review	Approved	Letter Label
Nov 26, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 11, 2013	Supplement 10REMS	Approved	Label Letter
Sep 9, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 29, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 21463
Drugs@FDA: Overview at FDA
Company: Endo Operations

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