Testosterone

ANDA 76744, held by Strides Pharma Intl. Testosterone.

As of Nov 14, 2026, ANDA 76744 (Testosterone), held by Strides Pharma Intl, was first approved by FDA on May 23, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: May 23, 2007
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Testosterone Gel 1% 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 10 submissions below

Date	Submission	Status	Documents
May 23, 2007	Original application	Approved	Review

Products

2 strengths and forms


Testosterone25MG/2.5GM PACKET · gel;transdermal	Testosterone	Rx
Testosterone50MG/5GM PACKET · gel;transdermal	Testosterone	Rx

All 10 submissions, including labeling and manufacturing supplements


Jul 16, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jun 3, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jun 3, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Jun 3, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Sep 25, 2015	Supplement 5REMS	Approved	None posted
Jun 30, 2015	Supplement 3Labeling	Approved	None posted
Jun 30, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jan 6, 2009	Supplement 1Labeling	Approved	None posted
May 23, 2007	Original application	Approved	Review

Identifiers

Application: ANDA 76744
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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