DALFAMPRIDINE
These highlights do not include all the information needed to use DALFAMPRIDINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DALFAMPRIDINE EXTENDED-RELEASE TABLETS. DALFAMPRIDINE extended-release tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
302c8270-4711-4ca4-bee8-be0738fbe094
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DALFAMPRIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-275
Application NumberANDA210158
Product Classification
M
Marketing Category
C73584
G
Generic Name
DALFAMPRIDINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DALFAMPRIDINEActive
Quantity: 10 mg in 1 1
Code: BH3B64OKL9
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT