🇺🇸 Treximet in United States

FDA authorised Treximet on 15 April 2008

Marketing authorisations

FDA — authorised 15 April 2008

  • Application: NDA021926
  • Marketing authorisation holder: CURRAX
  • Status: supplemented

FDA

  • Status: approved

FDA

  • Application: ANDA090753
  • Marketing authorisation holder: PAR PHARM
  • Local brand name: SUMATRIPTAN; NAPROXEN SODIUM
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA090930
  • Marketing authorisation holder: DR REDDYS LABS LTD
  • Local brand name: SUMATRIPTAN; NAPROXEN SODIUM
  • Indication: TABLET — ORAL
  • Status: approved

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Other Other approved in United States

Frequently asked questions

Is Treximet approved in United States?

Yes. FDA authorised it on 15 April 2008; FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Treximet in United States?

CURRAX holds the US marketing authorisation.