FDA.reportPublic FDA data

Application 215599

Type
ANDA
Sponsor
YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL50MGNoNo
002FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL100MGNoNo
003FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-817Flecainide Acetateflecainide acetateEpic Pharma, LLCANDACurrent
42806-818Flecainide Acetateflecainide acetateEpic Pharma, LLCANDACurrent
42806-819Flecainide Acetateflecainide acetateEpic Pharma, LLCANDACurrent