FDA — authorised 28 May 2004
- Marketing authorisation holder: ALLERGAN
- Status: approved
🇺🇸 Sanctura in United States
FDA authorised Sanctura on 28 May 2004
Marketing authorisations
FDA — authorised 12 October 2012
- Application: ANDA091289
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Status: approved
FDA — authorised 24 May 2013
- Application: ANDA201291
- Marketing authorisation holder: PADAGIS US
- Indication: Not Applicable
- Status: approved
FDA — authorised 30 August 2016
- Application: ANDA204945
- Marketing authorisation holder: HERITAGE PHARMS INC
- Status: approved
FDA — authorised 16 February 2022
- Application: ANDA215781
- Marketing authorisation holder: ZAMEER PHARMS
- Status: approved
FDA — authorised 18 June 2024
- Application: ANDA206472
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Sanctura 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 Sanctura approved in United States?
Yes. FDA authorised it on 28 May 2004; FDA authorised it on 12 October 2012; FDA authorised it on 24 May 2013.
Who is the marketing authorisation holder for Sanctura in United States?
ALLERGAN holds the US marketing authorisation.