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ACTIVE SUBSTANCE / INN

NERATINIB MALEATE

Brand name(s): NERATINIB MALEATE, NERLYNX
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
ANDA216236
NDA208051
ACTIVE SUBSTANCE
Neratinib Maleate
REGULATORS
FDA
SPONSORS / MAH
SANDOZ INC, PUMA BIOTECH
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NERLYNXNDA208051PUMA BIOTECHPrescription
NERATINIB MALEATEANDA216236SANDOZ INCNone (Tentative Approval)

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