🇺🇸 Postop oral oxycodone & acetaminophen in United States

FDA authorised Postop oral oxycodone & acetaminophen on 31 August 1976

Marketing authorisations

FDA — authorised 31 August 1976

  • Application: ANDA085106
  • Marketing authorisation holder: OZANTRI
  • Local brand name: PERCOCET
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 25 June 1999

  • Application: ANDA040330
  • Marketing authorisation holder: OZANTRI
  • Local brand name: PERCOCET
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 July 1999

  • Application: ANDA040341
  • Marketing authorisation holder: VINTAGE PHARMS LLC
  • Local brand name: PERCOCET
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

Postop oral oxycodone & acetaminophen in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Postop oral oxycodone & acetaminophen approved in United States?

Yes. FDA authorised it on 31 August 1976; FDA authorised it on 25 June 1999; FDA authorised it on 26 July 1999.

Who is the marketing authorisation holder for Postop oral oxycodone & acetaminophen in United States?

OZANTRI holds the US marketing authorisation.