FDA — authorised 5 April 2010
- Application: NDA022272
- Marketing authorisation holder: PURDUE PHARMA LP
- Local brand name: OXYCONTIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised OXYCONTIN® on 5 April 2010
Yes. FDA authorised it on 5 April 2010; FDA has authorised it.
PURDUE PHARMA LP holds the US marketing authorisation.