FDA — authorised 30 March 2010
- Application: NDA021201
- Marketing authorisation holder: CHEMISCH FBRK KRSSLR
- Status: supplemented
FDA authorised Asclera on 30 March 2010
Yes. FDA authorised it on 30 March 2010; FDA has authorised it.
CHEMISCH FBRK KRSSLR holds the US marketing authorisation.