FDA
- Application: ANDA220238
- Marketing authorisation holder: QILU PHARMACEUTICAL CO., LTD.
- Local brand name: ABEMACICLIB
- Indication: TABLET
- Status: approved
[^14C]-LY2835219 ([^14C]-LY2835219) regulatory status in United States.
Yes. FDA has authorised it.
QILU PHARMACEUTICAL CO., LTD. holds the US marketing authorisation.