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ACTIVE SUBSTANCE / INN

CLASCOTERONE

Brand name(s): WINLEVI, Winlevi
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Acne Vulgaris
NDA213433
ACTIVE SUBSTANCE
Clascoterone
REGULATORS
FDA · EMA
SPONSORS / MAH
SUN PHARM, Cassiopea S.p.A.
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
WINLEVINDA213433SUN PHARMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
WinleviCassiopea S.p.A.Authorised17/10/2025Acne Vulgaris

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