Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208051

NERLYNX (NERATINIB MALEATE)
EQ 40MG BASE Marketing Status: Prescription

Active Ingredient: NERATINIB MALEATE
Proprietary Name: NERLYNX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208051
Product Number: 001
Approval Date: Jul 17, 2017
Applicant Holder Full Name: PUMA BIOTECHNOLOGY INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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