FDA — authorised 31 December 1987
- Application: NDA019779
- Marketing authorisation holder: HARROW EYE
- Local brand name: IOPIDINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA authorised Iopidine on 31 December 1987
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 December 1987; FDA authorised it on 30 July 1993.
HARROW EYE holds the US marketing authorisation.