FDA — authorised 12 November 1957
- Application: NDA010996
- Marketing authorisation holder: XANODYNE PHARM
- Local brand name: DARVON W/ ASA
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised ASA evening on 12 November 1957
Yes. FDA authorised it on 12 November 1957; FDA authorised it on 9 September 1971; FDA authorised it on 9 September 1971.
XANODYNE PHARM holds the US marketing authorisation.