Tikosyn
TIKOSYN (dofetilide) Capsules
Approved
Approval ID
01f9fb69-2438-481c-b5ec-adebe7825253
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69189-5810
Application NumberNDA020931
Product Classification
M
Marketing Category
C73594
G
Generic Name
dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2017
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOFETILIDEActive
Quantity: 0.25 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT