FDA — authorised 20 November 2008
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
🇺🇸 Nucynta in United States
FDA authorised Nucynta on 20 November 2008
Marketing authorisations
FDA — authorised 20 November 2008
- Application: NDA022304
- Marketing authorisation holder: COLLEGIUM PHARM INC
- Local brand name: NUCYNTA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: NDA203794
- Marketing authorisation holder: COLLEGIUM PHARM INC
- Local brand name: NUCYNTA
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 May 2017
- Application: NDA200533
- Marketing authorisation holder: COLLEGIUM PHARM INC
- Indication: REMS
- Status: approved
FDA — authorised 27 January 2026
- Application: ANDA214378
- Marketing authorisation holder: HUMANWELL
- Status: approved
FDA
- Application: ANDA204971
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: TAPENTADOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA206418
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: TAPENTADOL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA204972
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: TAPENTADOL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Nucynta 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 Nucynta approved in United States?
Yes. FDA authorised it on 20 November 2008; FDA authorised it on 20 November 2008; FDA authorised it on 15 October 2012.
Who is the marketing authorisation holder for Nucynta in United States?
JANSSEN PHARMS holds the US marketing authorisation.