Testosterone

ANDA 204571, held by Actavis Labs Ut Inc. Testosterone.

As of Nov 14, 2026, ANDA 204571 (Testosterone), held by Actavis Labs Ut Inc, was first approved by FDA on Aug 5, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 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
Aug 5, 2015	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone10MG/0.5GM ACTUATION · gel, metered;transdermal	Testosterone	Rx

All 5 submissions, including labeling and manufacturing supplements


Jul 15, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Jun 30, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Jun 21, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jun 21, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Aug 5, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 204571
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories UT

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