🇺🇸 Ultravate Cream in United States

FDA authorised Ultravate Cream on 17 December 1990

Marketing authorisations

FDA — authorised 17 December 1990

  • Application: NDA019968
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: ULTRAVATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 27 December 1990

  • Application: NDA019967
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: ULTRAVATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 6 November 2015

  • Application: NDA208183
  • Marketing authorisation holder: LACER PHARMA
  • Local brand name: ULTRAVATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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Frequently asked questions

Is Ultravate Cream approved in United States?

Yes. FDA authorised it on 17 December 1990; FDA authorised it on 27 December 1990; FDA authorised it on 6 November 2015.

Who is the marketing authorisation holder for Ultravate Cream in United States?

SUN PHARM INDS INC holds the US marketing authorisation.