🇺🇸 SYMDEKO (COPACKAGED) in United States

FDA authorised SYMDEKO (COPACKAGED) on 12 February 2018

Marketing authorisations

FDA — authorised 12 February 2018

  • Application: NDA210491
  • Marketing authorisation holder: VERTEX PHARMS INC
  • Local brand name: SYMDEKO (COPACKAGED)
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is SYMDEKO (COPACKAGED) approved in United States?

Yes. FDA authorised it on 12 February 2018; FDA has authorised it.

Who is the marketing authorisation holder for SYMDEKO (COPACKAGED) in United States?

VERTEX PHARMS INC holds the US marketing authorisation.