🇺🇸 FOSAMPRENAVIR CALCIUM in United States

FDA authorised FOSAMPRENAVIR CALCIUM on 15 April 2016

Marketing authorisations

FDA — authorised 15 April 2016

  • Application: ANDA204060
  • Marketing authorisation holder: MYLAN
  • Local brand name: FOSAMPRENAVIR CALCIUM
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 November 2019

  • Application: ANDA204024
  • Marketing authorisation holder: SUN PHARM
  • Local brand name: FOSAMPRENAVIR CALCIUM
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: ANDA204130
  • Marketing authorisation holder: LUPIN LTD
  • Local brand name: FOSAMPRENAVIR CALCIUM
  • Indication: TABLET — ORAL
  • Status: approved

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FOSAMPRENAVIR CALCIUM 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 FOSAMPRENAVIR CALCIUM approved in United States?

Yes. FDA authorised it on 15 April 2016; FDA authorised it on 20 November 2019; FDA has authorised it.

Who is the marketing authorisation holder for FOSAMPRENAVIR CALCIUM in United States?

MYLAN holds the US marketing authorisation.