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ACTIVE SUBSTANCE / INN

INGENOL MEBUTATE

Brand name(s): Picato, INGENOL MEBUTATE, PICATO
FDA LISTED
EMA LISTED
WITHDRAWN
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA202833
ANDA209018
ACTIVE SUBSTANCE
Ingenol Mebutate
REGULATORS
FDA · EMA
SPONSORS / MAH
PADAGIS ISRAEL, LEO Laboratories Ltd., ACTAVIS LABS
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
INGENOL MEBUTATEANDA209018PADAGIS ISRAELDiscontinued
INGENOL MEBUTATEANDA209086ACTAVIS LABSNone (Tentative Approval)
PICATONDA202833LEO LABSDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
PicatoLEO Laboratories Ltd.Withdrawn15/11/2012Keratosis, Actinic

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