NDA 204886, held by Key Therap. Vorapaxar Sulfate.
As of Nov 14, 2026, NDA 204886 (Zontivity), held by Key Therap, was first approved by FDA on May 8, 2014, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZontivityEQ 2.08MG BASE · tablet;oral | Vorapaxar Sulfate | DiscontinuedReference drug |
| Nov 7, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Jul 14, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 16, 2015 | Supplement 2Labeling · Standard review | Approved | |
| May 8, 2014 | Original applicationNew molecular entity · 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
