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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205718

AKYNZEO (NETUPITANT; PALONOSETRON HYDROCHLORIDE)
300MG;EQ 0.5MG BASE
Marketing Status: Prescription
Active Ingredient: NETUPITANT; PALONOSETRON HYDROCHLORIDE
Proprietary Name: AKYNZEO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG;EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205718
Product Number: 001
Approval Date: Oct 10, 2014
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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