🇺🇸 Bictegravir, emtricitabine, and tenofovir alafenamide in United States

Bictegravir, emtricitabine, and tenofovir alafenamide (Bictegravir, emtricitabine, and tenofovir alafenamide) regulatory status in United States.

Marketing authorisations

FDA

  • Application: ANDA218766
  • Marketing authorisation holder: CIPLA LTD
  • Local brand name: BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
  • Indication: TABLET
  • Status: approved

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FDA

  • Application: ANDA216914
  • Marketing authorisation holder: CIPLA LTD
  • Local brand name: BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
  • Indication: TABLET
  • Status: approved

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Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Bictegravir, emtricitabine, and tenofovir alafenamide approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Bictegravir, emtricitabine, and tenofovir alafenamide in United States?

CIPLA LTD holds the US marketing authorisation.