FDA.reportPublic FDA data

Application 086066

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1771Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1771Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1771Isosorbide DinitrateIsosorbide DinitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1771Isosorbide DinitrateIsosorbide DinitrateWest-Ward Pharmaceuticals CorpANDACurrent
0615-1560Isosorbide DinitrateIsosorbide DinitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6619Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6619Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6619Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
0904-6619Isosorbide DinitrateIsosorbide DinitrateMajor PharmaceuticalsANDACurrent
51407-148Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply Inc.ANDACurrent
51407-148Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
51407-148Isosorbide DinitrateIsosorbide DinitrateGolden State Medical SupplyANDACurrent
51407-148Isosorbide DinitrateIsosorbide DinitrateGolden State Medical Supply, Inc.ANDACurrent
53808-0274IsosorbideISOSORBIDE DINITRATEState of Florida DOH Central PharmacyANDACurrent
53808-0275IsosorbideISOSORBIDE DINITRATEState of Florida DOH Central PharmacyANDACurrent
55154-7990Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7990Isosorbide DinitrateIsosorbide DinitrateCardinal Health 107, LLCANDACurrent
55154-7990Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7990Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
55154-7990Isosorbide DinitrateIsosorbide DinitrateCardinal HealthANDACurrent
59115-129IsosorbideIsosorbide DinitrateHikma PharmaceuticalANDACurrent
63629-2573Isosorbide DinitrateIsosorbide DinitrateBryant Ranch PrepackANDACurrent
63629-2573Isosorbide DinitrateIsosorbide DinitrateBryant Ranch PrepackANDACurrent
68001-374IsosorbideIsosorbide DinitrateBluePoint LaboratoriesANDACurrent
68151-2472Isosorbide DinitrateIsosorbide DinitrateCarilion Materials ManagementANDACurrent
70518-1435Isosorbide DinitrateIsosorbide DinitrateREMEDYREPACK INC.ANDACurrent
70518-1435Isosorbide DinitrateIsosorbide DinitrateREMEDYREPACK INC.ANDACurrent
70518-1435Isosorbide DinitrateIsosorbide DinitrateREMEDYREPACK INC.ANDACurrent
70518-1435Isosorbide DinitrateIsosorbide DinitrateREMEDYREPACK INC.ANDACurrent
70518-1435Isosorbide DinitrateIsosorbide DinitrateREMEDYREPACK INC.ANDACurrent