NDA 21745, held by Purdue Pharma. Tramadol Hydrochloride.
As of Nov 14, 2026, NDA 21745 (Ryzolt), held by Purdue Pharma, was first approved by FDA on Dec 30, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Ryzolt100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Tramadol Hydrochloride | DiscontinuedReference drug |
| Ryzolt200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Tramadol Hydrochloride | DiscontinuedReference drug |
| Ryzolt300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Tramadol Hydrochloride | DiscontinuedReference drug |
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
