🇺🇸 Amoxicillin and clavulanate in United States

FDA authorised Amoxicillin and clavulanate on 6 August 1984

Marketing authorisations

FDA — authorised 6 August 1984

  • Application: NDA050575
  • Marketing authorisation holder: US ANTIBIOTICS
  • Status: supplemented

FDA — authorised 14 March 2002

  • Application: ANDA065063
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 20 December 2011

  • Application: ANDA201090
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: approved

FDA — authorised 20 December 2011

  • Application: ANDA201091
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: supplemented

FDA — authorised 23 August 2016

  • Application: ANDA203824
  • Marketing authorisation holder: HIKMA PHARMS
  • Status: supplemented

FDA

  • Status: approved

Amoxicillin and clavulanate in other countries

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

Frequently asked questions

Is Amoxicillin and clavulanate approved in United States?

Yes. FDA authorised it on 6 August 1984; FDA authorised it on 14 March 2002; FDA authorised it on 20 December 2011.

Who is the marketing authorisation holder for Amoxicillin and clavulanate in United States?

US ANTIBIOTICS holds the US marketing authorisation.