FDA — authorised 8 February 2011
- Application: NDA022332
- Marketing authorisation holder: ELI LILLY CO
- Indication: Labeling
- Status: approved
🇺🇸 Cialis in United States
FDA authorised Cialis on 8 February 2011
Marketing authorisations
FDA — authorised 5 February 2019
- Application: ANDA210145
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA211839
- Marketing authorisation holder: TORRENT
- Status: approved
FDA — authorised 7 October 2019
- Application: ANDA207244
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 17 June 2022
- Application: NDA214522
- Marketing authorisation holder: CMP DEV LLC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
Cialis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Cialis approved in United States?
Yes. FDA authorised it on 8 February 2011; FDA authorised it on 5 February 2019; FDA authorised it on 26 March 2019.
Who is the marketing authorisation holder for Cialis in United States?
ELI LILLY CO holds the US marketing authorisation.