NDA 213182, held by Novo Nordisk Inc. Semaglutide.
As of Nov 13, 2026, NDA 213182 (Rybelsus), held by Novo Nordisk Inc, was first approved by FDA on Jan 16, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2020 | Original applicationNew indication · Standard review | Approved |
| Rybelsus3MG · tablet;oral | Semaglutide | Rx |
| Rybelsus7MG · tablet;oral | Semaglutide | Rx |
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
