Testosterone

NDA 202763, held by Ani Pharms. Testosterone.

As of Nov 13, 2026, NDA 202763 (Testosterone), held by Ani Pharms, was first approved by FDA on Feb 14, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2012
Review: Standard
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
Feb 14, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Testosterone25MG/2.5GM PACKET · gel;transdermal	Testosterone	Discontinued
Testosterone50MG/5GM PACKET · gel;transdermal	Testosterone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 25, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
May 11, 2015	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 23, 2014	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 19, 2014	Supplement 2Labeling · Standard review	Approved	Letter Label
Feb 14, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202763
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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