🇺🇸 Cefadroxil discontinued early in United States

FDA authorised Cefadroxil discontinued early on 9 July 1980

Marketing authorisations

FDA — authorised 9 July 1980

  • Application: NDA050537
  • Marketing authorisation holder: PFIZER
  • Local brand name: CLEOCIN
  • Indication: SWAB — TOPICAL
  • Status: approved

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FDA — authorised 6 August 1980

  • Application: NDA050528
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: DURICEF
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 12 September 1980

  • Application: NDA050527
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: DURICEF
  • Indication: FOR SUSPENSION — ORAL
  • Status: approved

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FDA — authorised 7 April 1986

  • Application: ANDA062644
  • Marketing authorisation holder: PFIZER
  • Local brand name: CLEOCIN
  • Indication: FOR SOLUTION — ORAL
  • Status: approved

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FDA — authorised 11 August 1992

  • Application: NDA050680
  • Marketing authorisation holder: PFIZER
  • Local brand name: CLEOCIN
  • Indication: CREAM — VAGINAL
  • Status: approved

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FDA — authorised 13 August 1999

  • Application: NDA050767
  • Marketing authorisation holder: PFIZER
  • Local brand name: CLEOCIN
  • Indication: SUPPOSITORY — VAGINAL
  • Status: approved

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Other Infectious Disease approved in United States

Frequently asked questions

Is Cefadroxil discontinued early approved in United States?

Yes. FDA authorised it on 9 July 1980; FDA authorised it on 6 August 1980; FDA authorised it on 12 September 1980.

Who is the marketing authorisation holder for Cefadroxil discontinued early in United States?

PFIZER holds the US marketing authorisation.