FDA
- Status: approved
🇺🇸 EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE in United States
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE) regulatory status in United States.
Marketing authorisations
FDA
- Application: NDA213509
- Marketing authorisation holder: MYLAN
- Local brand name: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
- Indication: TABLET — ORAL
- Status: approved
EFAVIRENZ, 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 EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE in United States?
MYLAN is the originator. The local marketing authorisation holder may differ — check the official source linked above.