🇺🇸 Estrobene in United States

FDA authorised Estrobene on 30 May 1973

Marketing authorisations

FDA — authorised 30 May 1973

  • Application: ANDA083003
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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FDA

  • Application: NDA004040
  • Marketing authorisation holder: LILLY
  • Local brand name: DIETHYLSTILBESTROL
  • Indication: SUPPOSITORY — VAGINAL
  • Status: approved

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FDA

  • Application: NDA004056
  • Marketing authorisation holder: BRISTOL MYERS SQUIBB
  • Local brand name: STILBESTROL
  • Indication: SUPPOSITORY — VAGINAL
  • Status: approved

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FDA

  • Application: NDA004041
  • Marketing authorisation holder: LILLY
  • Local brand name: DIETHYLSTILBESTROL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083002
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083004
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083005
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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FDA

  • Application: ANDA083006
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083007
  • Marketing authorisation holder: TABLICAPS
  • Local brand name: STILBESTROL
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: NDA004039
  • Marketing authorisation holder: LILLY
  • Local brand name: DIETHYLSTILBESTROL
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

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Estrobene in other countries

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

Other Pain approved in United States

Frequently asked questions

Is Estrobene approved in United States?

Yes. FDA authorised it on 30 May 1973; FDA has authorised it; FDA has authorised it.

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

TABLICAPS holds the US marketing authorisation.