Tikosyn
TIKOSYN (dofetilide) Capsules
Approved
Approval ID
b77b4388-36ec-4971-90a5-353879adb8b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 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 Code69189-5820
Application NumberNDA020931
Product Classification
M
Marketing Category
C73594
G
Generic Name
dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2017
FDA Product Classification
INGREDIENTS (5)
DOFETILIDEActive
Quantity: 0.5 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 10/12/2016
Drug/Laboratory Test Interactions
None known.