🇺🇸 Westcort in United States

FDA authorised Westcort on 17 March 1978

Marketing authorisations

FDA — authorised 17 March 1978

  • Marketing authorisation holder: RANBAXY
  • Status: approved

FDA — authorised 17 March 1978

  • Application: NDA017950
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: WESTCORT
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 8 August 1983

  • Application: NDA018726
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: WESTCORT
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 25 August 1998

  • Application: ANDA075042
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 25 August 1998

  • Application: ANDA075043
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 24 May 2000

  • Application: ANDA075666
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 31 July 2001

  • Application: ANDA075085
  • Marketing authorisation holder: FOUGERA PHARMS
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 12 October 2018

  • Application: ANDA211129
  • Marketing authorisation holder: GLENMARK PHARMS LTD
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 14 December 2018

  • Application: ANDA211750
  • Marketing authorisation holder: GLENMARK PHARMS LTD
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 15 August 2019

  • Application: ANDA210307
  • Marketing authorisation holder: LUPIN
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 4 March 2020

  • Application: ANDA211764
  • Marketing authorisation holder: COSETTE
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 11 February 2021

  • Application: ANDA213724
  • Marketing authorisation holder: COSETTE
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 4 November 2021

  • Application: ANDA211047
  • Marketing authorisation holder: ENCUBE ETHICALS
  • Local brand name: HYDROCORTISONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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Westcort in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Westcort approved in United States?

Yes. FDA authorised it on 17 March 1978; FDA authorised it on 17 March 1978; FDA authorised it on 8 August 1983.

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

RANBAXY holds the US marketing authorisation.