NDA 206089, held by Tolmar. Testosterone Undecanoate.
As of Nov 13, 2026, NDA 206089 (Jatenzo), held by Tolmar, was first approved by FDA on Mar 27, 2019, with 2 approved supplements and 2 published complete response letters.
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 22, 2018 | Testosterone undecanoate (TU) (oral) | Approved |
| Nov 3, 2014 | Testosterone undecanoate (oral)Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jatenzo158MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Jatenzo198MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Jatenzo237MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jul 11, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Mar 27, 2019 | Original applicationNew dosage form · Standard review | Approved |
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
