🇺🇸 Mefoxin In Sodium Chloride 0.9% In Plastic Container in United States

FDA authorised Mefoxin In Sodium Chloride 0.9% In Plastic Container on 18 October 1978

Marketing authorisations

FDA — authorised 18 October 1978

  • Status: approved

FDA — authorised 27 February 1997

  • Application: NDA050581
  • Marketing authorisation holder: MERCK
  • Local brand name: MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 3 July 2000

  • Application: ANDA065012
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 3 July 2000

  • Application: ANDA065011
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 September 2000

  • Application: ANDA065051
  • Marketing authorisation holder: HIKMA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 September 2000

  • Application: ANDA065050
  • Marketing authorisation holder: HIKMA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 January 2006

  • Application: ANDA065313
  • Marketing authorisation holder: HOSPIRA INC
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 13 February 2006

  • Application: ANDA065312
  • Marketing authorisation holder: HOSPIRA INC
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 12 June 2009

  • Application: ANDA065414
  • Marketing authorisation holder: ACS DOBFAR
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 4 February 2010

  • Application: NDA065214
  • Marketing authorisation holder: B BRAUN
  • Indication: Labeling
  • Status: approved

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FDA — authorised 26 February 2010

  • Application: ANDA065239
  • Marketing authorisation holder: HIKMA FARMACEUTICA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 12 March 2010

  • Application: ANDA065238
  • Marketing authorisation holder: HIKMA FARMACEUTICA
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 19 May 2010

  • Application: ANDA065415
  • Marketing authorisation holder: ACS DOBFAR
  • Local brand name: CEFOXITIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Mefoxin In Sodium Chloride 0.9% In Plastic Container in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is Mefoxin In Sodium Chloride 0.9% In Plastic Container approved in United States?

Yes. FDA authorised it on 18 October 1978; FDA authorised it on 27 February 1997; FDA authorised it on 3 July 2000.

Who is the marketing authorisation holder for Mefoxin In Sodium Chloride 0.9% In Plastic Container in United States?

Marketing authorisation holder not available in our data.