FDA.reportPublic FDA data

Application 076813

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-2230IsosorbideIsosorbide mononitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2230IsosorbideIsosorbide mononitrateWest-Ward Pharmaceuticals CorpANDACurrent
0143-2230IsosorbideIsosorbide mononitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2260IsosorbideIsosorbide mononitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2260IsosorbideIsosorbide mononitrateWest-Ward Pharmaceuticals CorpANDACurrent
0143-2260IsosorbideIsosorbide mononitrateHikma Pharmaceuticals USA Inc.ANDACurrent
0615-4544Isosorbide MononitrateIsosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4546Isosorbide MononitrateIsosorbide mononitrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
68071-4390IsosorbideIsosorbide mononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4390IsosorbideIsosorbide mononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4689IsosorbideIsosorbide mononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4689IsosorbideIsosorbide mononitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68151-1418IsosorbideIsosorbide mononitrateCarilion Materials ManagementANDACurrent
71335-0739IsosorbideIsosorbide mononitrateBryant Ranch PrepackANDACurrent
71335-0739IsosorbideIsosorbide mononitrateBryant Ranch PrepackANDACurrent