NDA 22219, held by Endo Operations. Testosterone Undecanoate.
As of Nov 14, 2026, NDA 22219 (Aveed), held by Endo Operations, was first approved by FDA on Mar 5, 2014, with 15 approved supplements and 0 published complete response letters.
AVEED 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 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 5, 2014 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aveed750MG/3ML (250MG/ML) · injectable;intramuscular | Testosterone Undecanoate | RxReference drug |
| Jul 11, 2025 | Supplement 21Labeling · Standard review | Approved | |
| Oct 8, 2024 | Supplement 20REMS | Approved | |
| May 26, 2022 | Supplement 19REMS | Approved | |
| Aug 16, 2021 | Supplement 15Labeling · Standard review | Approved | |
| Jun 28, 2021 | Supplement 16REMS | Approved | |
| Jun 30, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Mar 13, 2020 | Supplement 13Labeling · Standard review | Approved | |
| Dec 19, 2018 | Supplement 12REMS | Approved | |
| Sep 1, 2018 | Supplement 11REMS | Approved | |
| Jan 24, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Dec 9, 2016 | Supplement 8REMS | Approved | |
| Oct 25, 2016 | Supplement 9Labeling · Standard review | Approved | |
| May 11, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Mar 3, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Jun 19, 2014 | Supplement 1Labeling | Approved | |
| Mar 5, 2014 | 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
