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ACTIVE SUBSTANCE / INN

SODIUM PHENYLBUTYRATE

Brand name(s): Ammonaps, Pheburane, PHEBURANE, RELYVRIO, SODIUM PHENYLBUTYRATE, OLPRUVA, BUPHENYL
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA020572
NDA216660
ACTIVE SUBSTANCE
Sodium Phenylbutyrate
REGULATORS
FDA · EMA
SPONSORS / MAH
AMYLYX, Eurocept International B. V., HORIZON THERAP US
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SODIUM PHENYLBUTYRATEANDA090910ALVOGENDiscontinued
SODIUM PHENYLBUTYRATEANDA203918PH HEALTHPrescription
PHEBURANENDA216513MEDUNIKPrescription
RELYVRIONDA216660AMYLYXDiscontinued
OLPRUVANDA214860ACERPrescription
BUPHENYLNDA020572HORIZON THERAP USDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
PheburaneEurocept International B. V.Authorised30/07/2013Carbamoyl-Phosphate Synthase I Deficiency Disease
AmmonapsImmedica Pharma ABAuthorised07/12/1999Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosph…

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