Testosterone

NDA 203098, held by Perrigo Israel. Testosterone.

As of Nov 13, 2026, NDA 203098 (Testosterone), held by Perrigo Israel, was first approved by FDA on Jan 31, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2013
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jan 31, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Testosterone12.5MG/1.25GM ACTUATION · gel, metered;transdermal	Testosterone	Discontinued
Testosterone25MG/2.5GM PACKET · gel;transdermal	Testosterone	Discontinued
Testosterone50MG/5GM PACKET · gel;transdermal	Testosterone	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 25, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Feb 26, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
May 11, 2015	Supplement 6Labeling · Standard review	Approved	Letter Label
May 1, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 19, 2014	Supplement 2Labeling	Approved	Label Letter
Jan 31, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 203098
Drugs@FDA: Overview at FDA
Company: Perrigo Israel

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