FDA — authorised 19 August 2003
- Application: NDA021400
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: LEVITRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Testosterone Undecanoate and/or PDE-5 in United States
FDA authorised Testosterone Undecanoate and/or PDE-5 on 19 August 2003
Marketing authorisation
Testosterone Undecanoate and/or PDE-5 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 Testosterone Undecanoate and/or PDE-5 approved in United States?
Yes. FDA authorised it on 19 August 2003.
Who is the marketing authorisation holder for Testosterone Undecanoate and/or PDE-5 in United States?
BAYER HLTHCARE holds the US marketing authorisation.