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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022059

TYKERB (LAPATINIB DITOSYLATE)
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: LAPATINIB DITOSYLATE
Proprietary Name: TYKERB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022059
Product Number: 001
Approval Date: Mar 13, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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