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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-109
Application NumberNDA215887
Product Classification
M
Marketing Category
C73594
G
Generic Name
tofersen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateApril 25, 2023
FDA Product Classification
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