Testosterone

ANDA 204255, held by Padagis Israel. Testosterone.

As of Nov 14, 2026, ANDA 204255 (Testosterone), held by Padagis Israel, was first approved by FDA on Feb 28, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2017
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Testosterone Topical Solution is indicated for replacement therapy in 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 (FSH, LH) above the normal range.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 28, 2017	Original application	Approved	Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal	Testosterone	Rx

All 6 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 13Labeling · Standard review	Approved	None posted
May 31, 2019	Supplement 5REMS	Approved	None posted
May 10, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Apr 24, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Apr 24, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Feb 28, 2017	Original application	Approved	Label

Identifiers

Application: ANDA 204255
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