Testosterone

ANDA 204570, held by Actavis Labs Ut Inc. Testosterone.

As of Nov 14, 2026, ANDA 204570 (Testosterone), held by Actavis Labs Ut Inc, was first approved by FDA on Apr 10, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 10, 2019
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Testosterone gel 1.62% is indicated for 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 conditions such as 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 3 submissions below

Date	Submission	Status	Documents
Apr 10, 2019	Original application	Approved	Letter Letter Letter Letter

Products

3 strengths and forms


Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal	Testosterone	Rx
Testosterone1.62% (20.25MG/1.25GM PACKET) · gel;transdermal	Testosterone	Rx
Testosterone1.62% (40.5MG/2.5GM PACKET) · gel;transdermal	Testosterone	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 1, 2019	Supplement 2Labeling · Standard review	Approved	None posted
May 16, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Apr 10, 2019	Original application	Approved	Letter Letter Letter Letter

Identifiers

Application: ANDA 204570
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