🇺🇸 Intravesical Solution in United States

FDA authorised Intravesical Solution on 19 April 2019

Marketing authorisations

FDA — authorised 19 April 2019

  • Application: ANDA206430
  • Marketing authorisation holder: HIKMA
  • Status: approved

FDA

  • Status: approved

Intravesical Solution in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Intravesical Solution approved in United States?

Yes. FDA authorised it on 19 April 2019; FDA has authorised it.

Who is the marketing authorisation holder for Intravesical Solution in United States?

HIKMA holds the US marketing authorisation.