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As of Nov 14, 2026, ANDA 205781 (Testosterone), held by Padagis Israel, was first approved by FDA on Jul 12, 2017, with 1 approved supplement and 0 published complete response letters.
First approved: Jul 12, 2017
Review: Standard
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.
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
