🇺🇸 UVADEX in United States

FDA authorised UVADEX on 3 December 1954

Marketing authorisations

FDA — authorised 3 December 1954

  • Application: NDA009048
  • Marketing authorisation holder: VALEANT PHARM INTL
  • Local brand name: 8-MOP
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Status: approved

UVADEX in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is UVADEX approved in United States?

Yes. FDA authorised it on 3 December 1954; FDA has authorised it.

Who is the marketing authorisation holder for UVADEX in United States?

VALEANT PHARM INTL holds the US marketing authorisation.