FDA.reportPublic FDA data

Application 088088

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL20MGNoNo
002ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL10MGNoNo
003ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1772Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1772Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1772Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1772Isosorbide DinitrateIsosorbide DinitrateWest-Ward Pharmaceuticals CorpANDACurrent
0615-1575Isosorbide DinitrateIsosorbide DinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6620Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6620Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6620Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6620Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
51407-149Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply, Inc.ANDACurrent
51407-149Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
51407-149Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
51407-149Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply Inc.ANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7991Isosorbide DinitrateIsosorbide DinitrateCardinal Health 107, LLCANDACurrent
59115-130IsosorbideIsosorbide DinitrateHikma PharmaceuticalANDACurrent
68001-375IsosorbideIsosorbide DinitrateBluePoint LaboratoriesANDACurrent