ACTIVE SUBSTANCE / INN

SAPROPTERIN DIHYDROCHLORIDE

Brand name(s): ZELVYSIA, KUVAN, SAPROPTERIN DIHYDROCHLORIDE
FDA LISTED
PRESCRIPTION
ANDA218645
NDA022181
ACTIVE SUBSTANCE
Sapropterin Dihydrochloride
REGULATORS
FDA
SPONSORS / MAH
AUCTA, BIOMARIN PHARM, MICRO LABS
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SAPROPTERIN DIHYDROCHLORIDEANDA219511MICRO LABSPrescription
KUVANNDA022181BIOMARIN PHARMPrescription
ZELVYSIAANDA218645AUCTAPrescription

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