Testosterone

ANDA 204268, held by Padagis Israel. Testosterone.

As of Nov 14, 2026, ANDA 204268 (Testosterone), held by Padagis Israel, was first approved by FDA on Aug 4, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 4, 2015
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Aug 4, 2015	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal	Testosterone	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 27, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Aug 4, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 204268
Drugs@FDA: Overview at FDA
Company: Padagis 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