Xadago
These highlights do not include all the information needed to use XADAGO safely and effectively. See full prescribing information for XADAGO . XADAGO (safinamide) tablets, for oral use. Initial U.S. Approval: 2017
Approved
Approval ID
c4d65f28-983f-42b4-bb23-023ae0fe81b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
DUNS: 087875626
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
safinamide mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27505-110
Application NumberNDA207145
Product Classification
M
Marketing Category
C73594
G
Generic Name
safinamide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SAFINAMIDE MESYLATEActive
Quantity: 50 mg in 1 1
Code: YS90V3DTX0
Classification: ACTIM
safinamide mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27505-111
Application NumberNDA207145
Product Classification
M
Marketing Category
C73594
G
Generic Name
safinamide mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
SAFINAMIDE MESYLATEActive
Quantity: 100 mg in 1 1
Code: YS90V3DTX0
Classification: ACTIM