FDA — authorised 21 November 2003
- Application: NDA021368
- Marketing authorisation holder: LILLY
- Local brand name: CIALIS
- Indication: TABLET — ORAL
- Status: approved
FDA authorised tadalafil once a day [T(OaD)] on 21 November 2003
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 21 November 2003.
LILLY holds the US marketing authorisation.