🇺🇸 DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE in United States

DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE (DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE) regulatory status in United States.

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: NDA215448
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Local brand name: DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE in other countries

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

Other Other approved in United States

Frequently asked questions

Is DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE approved in United States?

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

Who is the marketing authorisation holder for DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE in United States?

AUROBINDO PHARMA USA is the originator. The local marketing authorisation holder may differ — check the official source linked above.