FDA
- Application: NDA215187
- Marketing authorisation holder: LUPIN PHARMS
- Local brand name: DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Emtricitabine / Tenofovir Disoproxil Pill in United States
Emtricitabine / Tenofovir Disoproxil Pill (Emtricitabine / Tenofovir Disoproxil Pill) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA213120
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DOLUTEGRAVIR; RILPIVIRINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA213556
- Marketing authorisation holder: SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD
- Local brand name: DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA217016
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA215319
- Marketing authorisation holder: LAURUS GENERICS INC
- Local brand name: DOLUTEGRAVIR
- Indication: FILM — ORAL
- Status: approved
FDA
- Application: NDA210787
- Marketing authorisation holder: LAURUS LABS LTD
- Local brand name: DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA210796
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
Other Infectious Disease / Virology approved in United States
Frequently asked questions
Is Emtricitabine / Tenofovir Disoproxil Pill approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Emtricitabine / Tenofovir Disoproxil Pill in United States?
LUPIN PHARMS holds the US marketing authorisation.