FDA — authorised 4 February 2009
- Application: ANDA078503
- Marketing authorisation holder: OSMOTICA PHARM US
- Status: supplemented
🇺🇸 Oxybutynin chloride, extended-release in United States
FDA authorised Oxybutynin chloride, extended-release on 4 February 2009
Marketing authorisations
FDA — authorised 27 May 2016
- Application: ANDA206121
- Marketing authorisation holder: UNIQUE
- Status: supplemented
Other Urology approved in United States
Frequently asked questions
Is Oxybutynin chloride, extended-release approved in United States?
Yes. FDA authorised it on 4 February 2009; FDA authorised it on 27 May 2016.
Who is the marketing authorisation holder for Oxybutynin chloride, extended-release in United States?
OSMOTICA PHARM US holds the US marketing authorisation.