POTELIGEO
These highlights do not include all the information needed to use POTELIGEO safely and effectively. See full prescribing information for POTELIGEO. POTELIGEO (mogamulizumab-kpkc) injection, for intravenous useInitial U.S. Approval: 2018
Approved
Approval ID
e53960ab-42a1-40d1-9c7d-eb013fe7f18f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
Kyowa Kirin, Inc.
DUNS: 014778321
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mogamulizumab-kpkc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-761
Application NumberBLA761051
Product Classification
M
Marketing Category
C73585
G
Generic Name
mogamulizumab-kpkc
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 25, 2023
FDA Product Classification
INGREDIENTS (7)
glycineInactive
Quantity: 112.5 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
mogamulizumabActive
Quantity: 4 mg in 1 mL
Code: YI437801BE
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
citric acid monohydrateInactive
Quantity: 2.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
polysorbate 80Inactive
Quantity: 1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT