Sorafenib
These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. SORAFENIB tablets, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
dae598f7-823f-405c-ae31-f924594187b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sorafenib
PRODUCT DETAILS
NDC Product Code0480-5425
Application NumberANDA209567
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 1, 2022
Generic NameSorafenib
INGREDIENTS (3)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SORAFENIB TOSYLATEActive
Quantity: 200 mg in 1 1
Code: 5T62Q3B36J
Classification: ACTIM