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ACTIVE SUBSTANCE / INN

GLYCEROL PHENYLBUTYRATE

Brand name(s): Ravicti, GLYCEROL PHENYLBUTYRATE, RAVICTI
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
NDA203284
ANDA215139
ACTIVE SUBSTANCE
Glycerol Phenylbutyrate
REGULATORS
FDA · EMA
SPONSORS / MAH
Immedica Pharma AB, ANNORA PHARMA, PH HEALTH
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RAVICTINDA203284HORIZON THERAP USPrescription
GLYCEROL PHENYLBUTYRATEANDA205742PH HEALTHPrescription
GLYCEROL PHENYLBUTYRATEANDA215139ANNORA PHARMANone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RavictiImmedica Pharma ABAuthorised26/11/2015Urea Cycle Disorders, Inborn

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