FDA — authorised 27 April 2012
- Application: NDA202276
- Marketing authorisation holder: VIVUS LLC
- Local brand name: STENDRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Stendra in United States
FDA authorised Stendra on 27 April 2012
Marketing authorisations
FDA — authorised 14 June 2024
- Application: ANDA209266
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
Stendra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Stendra approved in United States?
Yes. FDA authorised it on 27 April 2012; FDA authorised it on 14 June 2024.
Who is the marketing authorisation holder for Stendra in United States?
VIVUS LLC holds the US marketing authorisation.