Tikosyn
TIKOSYN (dofetilide) Capsules
Approved
Approval ID
37e125c9-cbcd-43a7-b1f8-81043ac1b721
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 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 Code69189-5800
Application NumberNDA020931
Product Classification
M
Marketing Category
C73594
G
Generic Name
dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2017
FDA Product Classification
INGREDIENTS (5)
DOFETILIDEActive
Quantity: 0.125 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT