FDA — authorised 2 March 2018
- Application: ANDA209498
- Marketing authorisation holder: QILU
- Status: supplemented
🇺🇸 TENOFOVIR DISOPROXIL in United States
FDA authorised TENOFOVIR DISOPROXIL on 2 March 2018 · 11,452 US adverse-event reports
Marketing authorisations
FDA — authorised 31 July 2018
- Application: ANDA206481
- Marketing authorisation holder: CHARTWELL
- Status: approved
FDA — authorised 4 September 2018
- Application: ANDA203041
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: supplemented
FDA — authorised 3 June 2019
- Application: ANDA206894
- Marketing authorisation holder: CIPLA
- Status: supplemented
FDA — authorised 4 June 2021
- Application: ANDA204131
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 11,452
Most-reported reactions
- Foetal Exposure During Pregnancy — 2,500 reports (21.83%)
- Maternal Exposure During Pregnancy — 1,871 reports (16.34%)
- Virologic Failure — 1,196 reports (10.44%)
- Drug Ineffective — 1,158 reports (10.11%)
- Abortion Spontaneous — 961 reports (8.39%)
- Pathogen Resistance — 914 reports (7.98%)
- Viral Mutation Identified — 815 reports (7.12%)
- Drug Resistance — 720 reports (6.29%)
- Osteoporosis — 668 reports (5.83%)
- Drug Interaction — 649 reports (5.67%)
TENOFOVIR DISOPROXIL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TENOFOVIR DISOPROXIL approved in United States?
Yes. FDA authorised it on 2 March 2018; FDA authorised it on 31 July 2018; FDA authorised it on 4 September 2018.
Who is the marketing authorisation holder for TENOFOVIR DISOPROXIL in United States?
QILU holds the US marketing authorisation.