FDA — authorised 20 December 2019
- Application: NDA209569
- Marketing authorisation holder: DUTCH OPHTHALMIC
- Local brand name: TISSUEBLUE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA authorised Tissueblue on 20 December 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 20 December 2019; FDA has authorised it.
DUTCH OPHTHALMIC holds the US marketing authorisation.