Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208434

ALECENSA (ALECTINIB HYDROCHLORIDE)
EQ 150MG BASE Marketing Status: Prescription

Active Ingredient: ALECTINIB HYDROCHLORIDE
Proprietary Name: ALECENSA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208434
Product Number: 001
Approval Date: Dec 11, 2015
Applicant Holder Full Name: HOFFMANN-LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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