NDC 0078-0958

KYMRIAH

Tisagenlecleucel

KYMRIAH is a Intravenous Injection, Suspension in the Cellular Therapy category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Tisagenlecleucel.

Product ID0078-0958_1c241cd5-121e-4238-8c86-b24548c4aa84
NDC0078-0958
Product TypeCellular Therapy
Proprietary NameKYMRIAH
Generic NameTisagenlecleucel
Dosage FormInjection, Suspension
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-05-01
Marketing CategoryBLA / BLA
Application NumberBLA125646
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameTISAGENLECLEUCEL
Active Ingredient Strength60000000 1/1
Pharm ClassesCD19-directed Chimeric Antigen Receptor [EPC],Genetically-modified Autologous T Cells [EPC],CD19 Receptor Interactions [MoA],T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0958-19

1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0958-19 [00078095819]

KYMRIAH INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125646
Product TypeCELLULAR THERAPY
Billing UnitEA
Marketing Start Date2018-05-01

Drug Details

Active Ingredients

IngredientStrength
TISAGENLECLEUCEL60000000 1/1

NDC Crossover Matching brand name "KYMRIAH" or generic name "Tisagenlecleucel"

NDCBrand NameGeneric Name
0078-0846KYMRIAHtisagenlecleucel
0078-0958KYMRIAHtisagenlecleucel

Trademark Results [KYMRIAH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYMRIAH
KYMRIAH
86202616 not registered Dead/Abandoned
Novartis AG
2014-02-24
KYMRIAH
KYMRIAH
86202611 not registered Dead/Abandoned
Novartis AG
2014-02-24
KYMRIAH
KYMRIAH
79219217 5404058 Live/Registered
NOVARTIS AG
2017-07-28

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