🇺🇸 Premarin in United States

FDA authorised Premarin on 17 November 1995

Marketing authorisations

FDA — authorised 17 November 1995

  • Application: NDA020527
  • Marketing authorisation holder: WYETH PHARMS
  • Local brand name: PREMPHASE 14/14
  • Indication: TABLET — ORAL-28
  • Status: approved

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FDA

  • Status: approved

Frequently asked questions

Is Premarin approved in United States?

Yes. FDA authorised it on 17 November 1995; FDA has authorised it.

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

WYETH PHARMS holds the US marketing authorisation.