🇺🇸 Xtampza ER in United States

FDA authorised Xtampza ER on 26 April 2016

Marketing authorisation

FDA — authorised 26 April 2016

  • Application: NDA208090
  • Marketing authorisation holder: COLLEGIUM PHARM INC
  • Local brand name: XTAMPZA ER
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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Other Pain Management approved in United States

Frequently asked questions

Is Xtampza ER approved in United States?

Yes. FDA authorised it on 26 April 2016.

Who is the marketing authorisation holder for Xtampza ER in United States?

COLLEGIUM PHARM INC holds the US marketing authorisation.