NDA 202020, held by Horizon. Prednisone.
As of Nov 13, 2026, NDA 202020 (Rayos), held by Horizon, was first approved by FDA on Jul 26, 2012, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rayos1MG · tablet, delayed release;oral | Prednisone | DiscontinuedReference drug |
| Rayos2MG · tablet, delayed release;oral | Prednisone | DiscontinuedReference drug |
| Rayos5MG · tablet, delayed release;oral | Prednisone | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Dec 27, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Jul 22, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 5, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 12, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 12, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 10, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 25, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 13, 2013 | Supplement 3Labeling · Standard review | Approved | |
| Mar 13, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 26, 2012 | 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