NDA 206099, held by Azurity. Sumatriptan Succinate.
As of Nov 13, 2026, NDA 206099 (Onzetra Xsail), held by Azurity, was first approved by FDA on Jan 27, 2016, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onzetra XsailEQ 11MG BASE · powder;nasal | Sumatriptan Succinate | DiscontinuedReference drug |
| Dec 20, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Jun 18, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Nov 16, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 27, 2016 | 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
