FDA — authorised 26 October 2001
- Application: NDA021356
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: VIREAD
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Viread in United States
FDA authorised Viread on 26 October 2001
Marketing authorisations
FDA — authorised 18 January 2012
- Application: NDA022577
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: VIREAD
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 26 January 2018
- Application: ANDA203232
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2018
- Application: ANDA206481
- Marketing authorisation holder: CHARTWELL
- Local brand name: TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA211337
- Marketing authorisation holder: REYOUNG
- Local brand name: TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA204402
- Marketing authorisation holder: LUPIN LTD
- Local brand name: TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
Viread in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Viread approved in United States?
Yes. FDA authorised it on 26 October 2001; FDA authorised it on 18 January 2012; FDA authorised it on 26 January 2018.
Who is the marketing authorisation holder for Viread in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.