Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210493

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AKYNZEO (FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE)
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Proprietary Name: AKYNZEO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210493
Product Number: 002
Approval Date: May 27, 2020
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Prescription
Patent and Exclusivity Information

AKYNZEO (FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE)
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Proprietary Name: AKYNZEO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210493
Product Number: 001
Approval Date: Apr 19, 2018
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Discontinued
Patent and Exclusivity Information