FDA — authorised 3 July 2013
- Application: NDA204242
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: ZUBSOLV
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA authorised Higher bioavailability BNX sublingual tablets on 3 July 2013
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 3 July 2013.
EDENBRIDGE PHARMS holds the US marketing authorisation.