FDA.reportPublic FDA data

Application 076278

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL50MGNoNo
002FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL100MGNoNo
003FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL150MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0010Flecainide Acetateflecainide acetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0011Flecainide Acetateflecainide acetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0012Flecainide Acetateflecainide acetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0179-0201Flecainide Acetateflecainide acetateKAISER FOUNDATION HOSPITALSANDACurrent
50090-1132Flecainide Acetateflecainide acetateA-S Medication SolutionsANDACurrent
50090-1132Flecainide Acetateflecainide acetateA-S Medication SolutionsANDACurrent
68151-1464Flecainide Acetateflecainide acetateCarilion Materials ManagementANDACurrent