FDA — authorised 16 December 2004
- Application: ANDA076831
- Marketing authorisation holder: PADAGIS US
- Status: approved
🇺🇸 Urispas in United States
FDA authorised Urispas on 16 December 2004
Marketing authorisations
FDA — authorised 30 November 2005
- Application: ANDA076835
- Marketing authorisation holder: EPIC PHARMA
- Status: approved
Urispas in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Urispas approved in United States?
Yes. FDA authorised it on 16 December 2004; FDA authorised it on 30 November 2005.
Who is the marketing authorisation holder for Urispas in United States?
PADAGIS US holds the US marketing authorisation.