FDA — authorised 10 January 1992
- Application: NDA019962
- Marketing authorisation holder: MELINTA THERAP
- Local brand name: TOPROL-XL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Seloken ZOK/Toprol-XL on 10 January 1992
Yes. FDA authorised it on 10 January 1992.
MELINTA THERAP holds the US marketing authorisation.