NDA 208088, held by Verity. Testosterone Undecanoate.
As of Nov 14, 2026, NDA 208088 (Tlando), held by Verity, was first approved by FDA on Mar 28, 2022, with 1 approved supplement and 0 published complete response letters.
TLANDO is 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'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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tlando112.5MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Jul 11, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Mar 28, 2022 | 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
