Testim

NDA 21454, held by Endo Operations. Testosterone.

As of Nov 15, 2026, NDA 21454 (Testim), held by Endo Operations, was first approved by FDA on Oct 31, 2002, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2002
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TESTIM is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 31, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testim50MG/5GM PACKET · gel;transdermal	Testosterone	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 36Labeling · Standard review	Approved	Letter Medication Guide Label
Aug 20, 2021	Supplement 25Labeling · Standard review	Approved	Label
Aug 20, 2021	Supplement 34Labeling · Standard review	Approved	Letter Label
Nov 30, 2020	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 30, 2020	Supplement 31Labeling · Standard review	Approved	Letter Label
May 30, 2019	Supplement 29REMS	Approved	Letter
May 10, 2019	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 25, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
May 11, 2015	Supplement 23Labeling	Approved	Label Letter
Apr 9, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 19, 2014	Supplement 21Labeling · Standard review	Approved	Label Letter
May 1, 2014	Supplement 20REMS	Approved	Letter
Jan 2, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 30, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 22, 2011	Supplement 14REMS	Approved	Label Letter
Sep 18, 2009	Supplement 8Labeling · Standard review	Approved	Letter Label
Oct 31, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21454
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