🇺🇸 Kenalog and Sensorcaine in United States

FDA authorised Kenalog and Sensorcaine on 3 December 1957

Marketing authorisations

FDA — authorised 3 December 1957

  • Application: NDA011161
  • Marketing authorisation holder: ASTELLAS
  • Local brand name: ARISTOCORT
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 11 March 1974

  • Application: ANDA083750
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 April 1975

  • Application: ANDA084340
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 October 1975

  • Application: ANDA084268
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 October 1975

  • Application: ANDA084319
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 October 1975

  • Application: ANDA084267
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 October 1975

  • Application: ANDA084318
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 October 1975

  • Application: ANDA084320
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 4 November 1975

  • Application: ANDA084286
  • Marketing authorisation holder: BARR
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 February 1977

  • Application: ANDA084270
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 July 1982

  • Application: ANDA085601
  • Marketing authorisation holder: SANDOZ
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084020
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084708
  • Marketing authorisation holder: ROXANE
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084709
  • Marketing authorisation holder: ROXANE
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084406
  • Marketing authorisation holder: MYLAN
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084775
  • Marketing authorisation holder: TEVA
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084707
  • Marketing authorisation holder: ROXANE
  • Local brand name: TRIAMCINOLONE
  • Indication: TABLET — ORAL
  • Status: approved

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Frequently asked questions

Is Kenalog and Sensorcaine approved in United States?

Yes. FDA authorised it on 3 December 1957; FDA authorised it on 11 March 1974; FDA authorised it on 22 April 1975.

Who is the marketing authorisation holder for Kenalog and Sensorcaine in United States?

ASTELLAS holds the US marketing authorisation.