NDA 21693, held by Shionogi Inc. Tramadol Hydrochloride.
As of Nov 14, 2026, NDA 21693 (Rybix Odt), held by Shionogi Inc, was first approved by FDA on May 5, 2005, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rybix Odt50MG · tablet, orally disintegrating;oral | Tramadol Hydrochloride | Discontinued |
| Aug 13, 2010 | Supplement 2Labeling | Approved | |
| Jun 25, 2010 | Supplement 4Labeling | Approved | |
| Jul 12, 2006 | Supplement 1Manufacturing | Approved | |
| May 5, 2005 | 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
