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ACTIVE SUBSTANCE / INN

ERDAFITINIB

Brand name(s): Balversa, ERDAFITINIB, BALVERSA
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA218578
Urologic Neoplasms
ACTIVE SUBSTANCE
Erdafitinib
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International N.V., JANSSEN BIOTECH, NATCO PHARMA LTD
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ERDAFITINIBANDA218578NATCO PHARMA LTDNone (Tentative Approval)
BALVERSANDA212018JANSSEN BIOTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
BalversaJanssen-Cilag International N.V.Authorised22/08/2024Urologic Neoplasms

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