🇺🇸 Dihydrex in United States

FDA authorised Dihydrex on 14 October 1960

Marketing authorisations

FDA — authorised 14 October 1960

  • Application: NDA012489
  • Marketing authorisation holder: AH ROBINS INC
  • Local brand name: EXNA
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 November 1976

  • Application: ANDA083206
  • Marketing authorisation holder: PVT FORM
  • Local brand name: BENZTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: NDA012128
  • Marketing authorisation holder: PFIZER
  • Local brand name: URESE
  • Indication: TABLET — ORAL
  • Status: approved

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Other Cardiovascular approved in United States

Frequently asked questions

Is Dihydrex approved in United States?

Yes. FDA authorised it on 14 October 1960; FDA authorised it on 19 November 1976; FDA has authorised it.

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

AH ROBINS INC holds the US marketing authorisation.