NDA 20932, held by Roxane. Oxycodone Hydrochloride.
As of Nov 13, 2026, NDA 20932 (Roxicodone), held by Roxane, was first approved by FDA on Oct 26, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Roxicodone10MG · tablet, extended release;oral | Oxycodone Hydrochloride | Discontinued |
| Roxicodone30MG · tablet, extended release;oral | Oxycodone Hydrochloride | Discontinued |
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
