Viltepso
These highlights do not include all the information needed to use VILTEPSO safely and effectively. See full prescribing information for VILTEPSO. VILTEPSO (viltolarsen) injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
NS Pharma, Inc.
DUNS: 135666654
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
viltolarsen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73292-011
Application NumberNDA212154
Product Classification
M
Marketing Category
C73594
G
Generic Name
viltolarsen
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 3, 2020
FDA Product Classification
INGREDIENTS (5)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
viltolarsenActive
Quantity: 250 mg in 1 1
Code: SXA7YP6EKX
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT