🇺🇸 Betneval ointment - Non-desquamated zone in United States

FDA authorised Betneval ointment - Non-desquamated zone on 17 February 1969

Marketing authorisations

FDA — authorised 17 February 1969

  • Application: NDA016740
  • Marketing authorisation holder: SCHERING
  • Local brand name: VALISONE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 10 January 1973

  • Application: NDA016932
  • Marketing authorisation holder: SCHERING
  • Local brand name: VALISONE
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 30 June 1983

  • Application: NDA018839
  • Marketing authorisation holder: ROACO
  • Local brand name: BETADERM
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 31 August 1983

  • Application: NDA018867
  • Marketing authorisation holder: SAVAGE LABS
  • Local brand name: BETATREX
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 31 August 1983

  • Application: NDA018865
  • Marketing authorisation holder: FOUGERA PHARMS INC
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 31 August 1983

  • Application: NDA018866
  • Marketing authorisation holder: FOUGERA PHARMS INC
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 10 October 1984

  • Application: ANDA070051
  • Marketing authorisation holder: ACTAVIS MID ATLANTIC
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 10 October 1984

  • Application: ANDA070050
  • Marketing authorisation holder: ACTAVIS MID ATLANTIC
  • Local brand name: VALNAC
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 14 May 1985

  • Application: ANDA070062
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 27 June 1985

  • Application: ANDA070072
  • Marketing authorisation holder: COSETTE
  • Local brand name: BETA-VAL
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 31 July 1985

  • Application: ANDA070052
  • Marketing authorisation holder: SENORES PHARMS
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 19 December 1985

  • Application: ANDA070069
  • Marketing authorisation holder: COSETTE
  • Local brand name: BETA-VAL
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA — authorised 6 January 1988

  • Application: ANDA072041
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: DERMABET
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 22 April 1988

  • Application: ANDA071883
  • Marketing authorisation holder: TEVA PHARMS
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA — authorised 12 August 1992

  • Application: ANDA070053
  • Marketing authorisation holder: PERRIGO NEW YORK
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 28 February 1999

  • Application: NDA020934
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: LUXIQ
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA — authorised 26 November 2012

  • Application: ANDA078337
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA — authorised 24 May 2017

  • Application: ANDA207144
  • Marketing authorisation holder: INGENUS PHARMS LLC
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA — authorised 24 May 2017

  • Application: ANDA208204
  • Marketing authorisation holder: TARO
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA — authorised 18 April 2023

  • Application: ANDA210639
  • Marketing authorisation holder: XIROMED
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA — authorised 22 August 2024

  • Application: ANDA215832
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: AEROSOL, FOAM — TOPICAL
  • Status: approved

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FDA

  • Application: ANDA070485
  • Marketing authorisation holder: PHARMAFAIR
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA

  • Application: ANDA070486
  • Marketing authorisation holder: PHARMAFAIR
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA

  • Application: ANDA071478
  • Marketing authorisation holder: PERRIGO NEW YORK
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA

  • Application: NDA018860
  • Marketing authorisation holder: PHARMADERM
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA

  • Application: NDA018864
  • Marketing authorisation holder: PHARMADERM
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: OINTMENT — TOPICAL
  • Status: approved

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FDA

  • Application: NDA018870
  • Marketing authorisation holder: PHARMADERM
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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FDA

  • Application: ANDA070484
  • Marketing authorisation holder: PHARMAFAIR
  • Local brand name: BETAMETHASONE VALERATE
  • Indication: LOTION — TOPICAL
  • Status: approved

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Frequently asked questions

Is Betneval ointment - Non-desquamated zone approved in United States?

Yes. FDA authorised it on 17 February 1969; FDA authorised it on 10 January 1973; FDA authorised it on 30 June 1983.

Who is the marketing authorisation holder for Betneval ointment - Non-desquamated zone in United States?

SCHERING holds the US marketing authorisation.