FDA.reportPublic FDA data

Application 086067

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1769Isosorbide DinitrateIsosorbide DinitrateWest-Ward Pharmaceuticals CorpANDACurrent
0143-1769Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1769Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1769Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
51407-147Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply Inc.ANDACurrent
51407-147Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply, Inc.ANDACurrent
51407-147Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
51407-147Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
59115-143IsosorbideIsosorbide DinitrateHikma PharmaceuticalANDACurrent
68001-373IsosorbideIsosorbide DinitrateBluePoint LaboratoriesANDACurrent
68151-2475Isosorbide DinitrateIsosorbide DinitrateCarilion Materials ManagementANDACurrent