QALSODY
These highlights do not include all the information needed to use QALSODY ™ safely and effectively. See full prescribing information for QALSODY. QALSODY (tofersen) injection, for intrathecal use Initial U.S. Approval: 2023
Approved
Approval ID
81356b45-1cb7-4eef-88ea-e44cc18b47c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2023
Manufacturers
FDA
Biogen Inc.
DUNS: 121376230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tofersen
PRODUCT DETAILS
NDC Product Code64406-109
Application NumberNDA215887
Marketing CategoryC73594
Route of AdministrationINTRATHECAL
Effective DateApril 25, 2023
Generic Nametofersen
INGREDIENTS (8)
tofersenActive
Quantity: 100 mg in 15 mL
Code: 2NU6F9601K
Classification: ACTIB
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
calcium chlorideInactive
Code: M4I0D6VV5M
Classification: IACT
magnesium chlorideInactive
Code: 02F3473H9O
Classification: IACT
sodium phosphate, dibasic, unspecified formInactive
Code: GR686LBA74
Classification: IACT