NDC 69639-105

AKYNZEO

Fosnetupitant And Palonosetron

AKYNZEO is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Fosnetupitant; Palonosetron Hydrochloride.

Product ID69639-105_7c25ad52-d737-489f-b229-1e2a6fa0add1
NDC69639-105
Product TypeHuman Prescription Drug
Proprietary NameAKYNZEO
Generic NameFosnetupitant And Palonosetron
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-06-15
Marketing CategoryNDA / NDA
Application NumberNDA210493
Labeler NameHelsinn Therapeutics (U.S.), Inc.
Substance NameFOSNETUPITANT; PALONOSETRON HYDROCHLORIDE
Active Ingredient Strength260 mg/20mL; mg/20mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69639-105-01

1 VIAL in 1 CARTON (69639-105-01) > 20 mL in 1 VIAL
Marketing Start Date2020-06-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "AKYNZEO" or generic name "Fosnetupitant And Palonosetron"

NDCBrand NameGeneric Name
69639-101AKYNZEONetupitant and Palonosetron
69639-102AKYNZEOFosnetupitant and Palonosetron
69639-105AKYNZEOFosnetupitant and Palonosetron

Trademark Results [AKYNZEO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AKYNZEO
AKYNZEO
85264083 4066299 Live/Registered
Helsinn Healthcare S.A.
2011-03-11
AKYNZEO
AKYNZEO
79140820 4595036 Live/Registered
Helsinn Healthcare SA
2013-10-17

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