🇺🇸 hydrocortisone 17-butyrate 0.1% Cream preparation in United States

FDA authorised hydrocortisone 17-butyrate 0.1% Cream preparation on 31 March 1982

Marketing authorisations

FDA — authorised 31 March 1982

  • Application: NDA018514
  • Marketing authorisation holder: BAUSCH
  • Local brand name: LOCOID
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 29 October 1982

  • Application: NDA018652
  • Marketing authorisation holder: PRECISION DERMAT
  • Local brand name: LOCOID
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 18 May 2007

  • Application: NDA022076
  • Marketing authorisation holder: BAUSCH
  • Local brand name: LOCOID
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: NDA018795
  • Marketing authorisation holder: YAMANOUCHI
  • Local brand name: LOCOID
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA

  • Application: NDA019819
  • Marketing authorisation holder: YAMANOUCHI
  • Local brand name: LOCOID
  • Indication: SOLUTION — TOPICAL
  • Status: approved

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hydrocortisone 17-butyrate 0.1% Cream preparation 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 hydrocortisone 17-butyrate 0.1% Cream preparation approved in United States?

Yes. FDA authorised it on 31 March 1982; FDA authorised it on 29 October 1982; FDA authorised it on 18 May 2007.

Who is the marketing authorisation holder for hydrocortisone 17-butyrate 0.1% Cream preparation in United States?

BAUSCH holds the US marketing authorisation.