FDA — authorised 21 November 2003
- Application: NDA021368
- Marketing authorisation holder: LILLY
- Local brand name: CIALIS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cialis in United States
FDA authorised Cialis on 21 November 2003
Marketing authorisations
FDA — authorised 22 May 2018
- Application: ANDA090141
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2019
- Application: ANDA210145
- Marketing authorisation holder: DR REDDYS
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2019
- Application: ANDA206286
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2019
- Application: ANDA210392
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA209654
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA211335
- Marketing authorisation holder: SUNSHINE
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA208934
- Marketing authorisation holder: SUN PHARM
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA206693
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA206285
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA212062
- Marketing authorisation holder: TORRENT
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA210069
- Marketing authorisation holder: DR REDDYS
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA210420
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA209744
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA204809
- Marketing authorisation holder: ALEMBIC
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2019
- Application: ANDA205885
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2020
- Application: ANDA213496
- Marketing authorisation holder: SUNSHINE
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2020
- Application: ANDA210716
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2021
- Application: ANDA215556
- Marketing authorisation holder: VKT PHARMA
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2022
- Application: ANDA216932
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: ALYQ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 2023
- Application: ANDA212515
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TADALAFIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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 Cardiovascular approved in United States
Frequently asked questions
Is Cialis approved in United States?
Yes. FDA authorised it on 21 November 2003; FDA authorised it on 22 May 2018; FDA authorised it on 5 February 2019.
Who is the marketing authorisation holder for Cialis in United States?
LILLY holds the US marketing authorisation.