FDA — authorised 3 December 1954
- Application: NDA009048
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: 8-MOP
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised UVADEX on 3 December 1954
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 December 1954; FDA has authorised it.
VALEANT PHARM INTL holds the US marketing authorisation.