NDC 0078-1007

KESIMPTA

Ofatumumab

KESIMPTA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ofatumumab.

Product ID0078-1007_3d92e626-19d1-4800-8d68-f3380a00787c
NDC0078-1007
Product TypeHuman Prescription Drug
Proprietary NameKESIMPTA
Generic NameOfatumumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2009-10-26
Marketing CategoryBLA / BLA
Application NumberBLA125326
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameOFATUMUMAB
Active Ingredient Strength20 mg/.4mL
Pharm ClassesCD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-1007-68

1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) > .4 mL in 1 SYRINGE, GLASS
Marketing Start Date2020-08-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "KESIMPTA" or generic name "Ofatumumab"

NDCBrand NameGeneric Name
0078-1007KESIMPTAofatumumab
0078-0669ARZERRAofatumumab
0078-0690ARZERRAofatumumab

Trademark Results [KESIMPTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KESIMPTA
KESIMPTA
79227649 5537963 Live/Registered
Novartis AG
2018-01-15

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