🇺🇸 Clobetasol Propionate 0.05% Lotion in United States

FDA authorised Clobetasol Propionate 0.05% Lotion on 24 July 2003

Marketing authorisations

FDA — authorised 24 July 2003

  • Application: NDA021535
  • Marketing authorisation holder: GALDERMA LABS LP
  • Local brand name: CLOBEX
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 27 October 2005

  • Application: NDA021835
  • Marketing authorisation holder: GALDERMA LABS LP
  • Local brand name: CLOBEX
  • Indication: SPRAY — TOPICAL
  • Status: approved

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Frequently asked questions

Is Clobetasol Propionate 0.05% Lotion approved in United States?

Yes. FDA authorised it on 24 July 2003; FDA authorised it on 27 October 2005.

Who is the marketing authorisation holder for Clobetasol Propionate 0.05% Lotion in United States?

GALDERMA LABS LP holds the US marketing authorisation.