🇺🇸 Conventional glucocortidois in United States

FDA authorised Conventional glucocortidois on 2 November 1951

Marketing authorisations

FDA — authorised 2 November 1951

  • Application: NDA008126
  • Marketing authorisation holder: PHARMACIA AND UPJOHN
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 3 January 1972

  • Application: ANDA080630
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 13 June 1972

  • Application: ANDA080776
  • Marketing authorisation holder: HIKMA INTL PHARMS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 9 July 1973

  • Application: ANDA083536
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 August 1973

  • Application: ANDA083471
  • Marketing authorisation holder: BARR
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 October 1974

  • Application: ANDA080694
  • Marketing authorisation holder: CHARTWELL MOLECULAR
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 January 1975

  • Application: ANDA084246
  • Marketing authorisation holder: EVERYLIFE
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 23 February 1977

  • Application: NDA009458
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 March 1978

  • Application: ANDA085677
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: CORTISONE ACETATE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 15 May 1978

  • Application: ANDA085884
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083147
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: CORTISONE ACETATE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA080836
  • Marketing authorisation holder: ELKINS SINN
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA080493
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA085736
  • Marketing authorisation holder: HEATHER
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA080731
  • Marketing authorisation holder: INWOOD LABS
  • Local brand name: CORTISONE ACETATE
  • Indication: TABLET — ORAL
  • Status: approved

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Other Immunology, Rheumatology, Endocrinology approved in United States

Frequently asked questions

Is Conventional glucocortidois approved in United States?

Yes. FDA authorised it on 2 November 1951; FDA authorised it on 3 January 1972; FDA authorised it on 13 June 1972.

Who is the marketing authorisation holder for Conventional glucocortidois in United States?

PHARMACIA AND UPJOHN holds the US marketing authorisation.