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FDA Product

AKYNZEO

Product approved by U.S. Food and Drug Administration (US)

Basic Information

AKYNZEO

69639-102

Regulatory Information

69639-102

NDA210493

C73594

February 10, 2023

USA

These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. AKYNZEO® (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous useInitial U.S. Approval: 2018

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

829472583

Active Ingredients

PALONOSETRON HYDROCHLORIDE

Quantity: 0.28 mg in 1 1

Code: 23310D4I19

Class Code: ACTIM

FOSNETUPITANT

Quantity: 260 mg in 1 1

Code: T672P80L2S

Class Code: ACTIM

Inactive Ingredients

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

FOSNETUPITANT

Code: T672P80L2S

PALONOSETRON

Code: 5D06587D6R

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