FDA — authorised 5 April 2010
- Application: NDA022272
- Marketing authorisation holder: PURDUE PHARMA LP
- Local brand name: OXYCONTIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 OxyContin in United States
FDA authorised OxyContin on 5 April 2010
Marketing authorisations
FDA — authorised 22 September 2015
- Application: ANDA202662
- Marketing authorisation holder: EPIC PHARMA LLC
- Status: approved
FDA — authorised 16 December 2016
- Application: NDA208090
- Marketing authorisation holder: COLLEGIUM PHARM INC
- Indication: Labeling
- Status: approved
FDA — authorised 1 February 2019
- Application: ANDA206914
- Marketing authorisation holder: PHARM ASSOC
- Status: approved
FDA — authorised 2 June 2021
- Application: ANDA213761
- Marketing authorisation holder: QUAGEN
- Status: approved
FDA — authorised 22 December 2025
- Application: ANDA201972
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Indication: Labeling
- Status: approved
The FDA approved the marketing authorisation for OxyContin, a medication used for pain management, on 22 December 2025. The approval was granted to AUROLIFE PHARMA LLC, the marketing authorisation holder. The approval was based on a standard application pathway.
OxyContin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is OxyContin approved in United States?
Yes. FDA authorised it on 5 April 2010; FDA authorised it on 22 September 2015; FDA authorised it on 16 December 2016.
Who is the marketing authorisation holder for OxyContin in United States?
PURDUE PHARMA LP holds the US marketing authorisation.