NDA 21732, held by Endo Operations. Histrelin Acetate.
As of Nov 14, 2026, NDA 21732 (Vantas), held by Endo Operations, was first approved by FDA on Oct 12, 2004, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vantas50MG · implant;subcutaneous | Histrelin Acetate | DiscontinuedReference drug |
| May 6, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Sep 23, 2025 | Supplement 25Labeling · Standard review | Approved | |
| Aug 23, 2022 | Supplement 24Labeling · Standard review | Approved | |
| Dec 16, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Feb 11, 2019 | Supplement 22Labeling · Standard review | Approved | |
| Jul 31, 2015 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jul 8, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Jan 9, 2014 | Supplement 15Manufacturing · Standard review | Approved | |
| Apr 4, 2013 | Supplement 18Labeling · Standard review | Approved | |
| Feb 4, 2011 | Supplement 7Labeling · Standard review | Approved | |
| Feb 4, 2011 | Supplement 10Labeling | Approved | |
| Feb 4, 2011 | Supplement 12Labeling · Standard review | Approved | |
| Jan 14, 2011 | Supplement 13Labeling | Approved | |
| Sep 25, 2008 | Supplement 5Manufacturing | Approved | None posted |
| Oct 12, 2004 | 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
