Exservan
These highlights do not include all the information needed to use EXSERVAN™ safely and effectively. See full prescribing information for EXSERVAN. EXSERVAN (riluzole) oral filmInitial U.S. Approval: 1995
Approved
Approval ID
f981ebe9-f931-4b4e-b7d1-2133f7aa6d66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
Mitsubishi Tanabe Pharma America, Inc.
DUNS: 080161422
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
riluzole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70510-2201
Application NumberNDA212640
Product Classification
M
Marketing Category
C73594
G
Generic Name
riluzole
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2021
FDA Product Classification
INGREDIENTS (12)
RILUZOLEActive
Quantity: 50 mg in 1 1
Code: 7LJ087RS6F
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PULLULANInactive
Code: 8ZQ0AYU1TT
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
POLACRILINInactive
Code: RCZ785HI7S
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
GLYCERYL MONOOLEATEInactive
Code: C4YAD5F5G6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT