🇺🇸 Gynorest in United States

Gynorest (DYDROGESTERONE) regulatory status in United States.

Marketing authorisations

FDA

  • Marketing authorisation holder: SOLVAY
  • Status: approved

FDA

  • Application: NDA017388
  • Marketing authorisation holder: SOLVAY
  • Local brand name: GYNOREST
  • Indication: TABLET — ORAL
  • Status: approved

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Gynorest in other countries

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

Other Other approved in United States

Frequently asked questions

Is Gynorest approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

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

SOLVAY holds the US marketing authorisation.