NDC 73042-201

DANYELZA

Naxitamab

DANYELZA is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Y-mabs Therapeutics, Inc.. The primary component is Naxitamab.

Product ID73042-201_117c2751-cc38-4d07-9d3c-339b2fe18916
NDC73042-201
Product TypeHuman Prescription Drug
Proprietary NameDANYELZA
Generic NameNaxitamab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-11-25
Marketing CategoryBLA / BLA
Application NumberBLA761171
Labeler NameY-mAbs Therapeutics, Inc.
Substance NameNAXITAMAB
Active Ingredient Strength40 mg/10mL
Pharm ClassesGlycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 73042-201-01

1 VIAL, SINGLE-DOSE in 1 CARTON (73042-201-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-11-25
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [DANYELZA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DANYELZA
DANYELZA
88320046 not registered Live/Pending
Y-mAbs Therapeutics, Inc
2019-02-28

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