Androderm

NDA 20489, held by Abbvie. Testosterone.

As of Nov 13, 2026, NDA 20489 (Androderm), held by Abbvie, was first approved by FDA on Sep 29, 1995, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1995
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 20, 2011	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 29, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Androderm2.5MG/24HR · film, extended release;transdermal	Testosterone	Discontinued
Androderm5MG/24HR · film, extended release;transdermal	Testosterone	Discontinued
Androderm2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Testosterone	DiscontinuedReference drug
Androderm4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Testosterone	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 11, 2020	Supplement 36Labeling · Standard review	Approved	Letter Label
Oct 25, 2016	Supplement 34Labeling · Standard review	Approved	Review Label Letter
May 11, 2015	Supplement 33Labeling · Standard review	Approved	Label Letter
Apr 30, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 19, 2014	Supplement 31Labeling · Standard review	Approved	Review Letter Label
Jan 16, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 26, 2012	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 20, 2011	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 19, 2006	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 27, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 9, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Jan 15, 2002	Supplement 7Labeling · Standard review	Approved	Review Letter
Oct 24, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 13, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 9, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 29, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 18, 1998	Supplement 4Labeling · Standard review	Approved	None posted
May 2, 1997	Supplement 3Manufacturing · Standard review	Approved	Review
Apr 22, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 10, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Sep 29, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20489
Drugs@FDA: Overview at FDA
Company: AbbVie

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