🇺🇸 Extended Release Tacrolimus Tablets in United States

FDA authorised Extended Release Tacrolimus Tablets on 10 July 2015

Marketing authorisations

FDA — authorised 10 July 2015

  • Application: NDA206406
  • Marketing authorisation holder: VELOXIS PHARMS INC
  • Local brand name: ENVARSUS XR
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA

  • Status: approved

Extended Release Tacrolimus Tablets 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 Extended Release Tacrolimus Tablets approved in United States?

Yes. FDA authorised it on 10 July 2015; FDA has authorised it.

Who is the marketing authorisation holder for Extended Release Tacrolimus Tablets in United States?

VELOXIS PHARMS INC holds the US marketing authorisation.