FDA.reportPublic FDA data

Application 077459

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0123Losartan PotassiumLosartan PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0123Losartan PotassiumLosartan PotassiumWest-Ward PharmaceuticalsANDACurrent
0054-0123Losartan PotassiumLosartan PotassiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0124Losartan PotassiumLosartan PotassiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0124Losartan PotassiumLosartan PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0124Losartan PotassiumLosartan PotassiumWest-Ward PharmaceuticalsANDACurrent
0054-0125Losartan PotassiumLosartan PotassiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0125Losartan PotassiumLosartan PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0125Losartan PotassiumLosartan PotassiumWest-Ward PharmaceuticalsANDACurrent
68071-4380Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4380Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4380Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4597Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5095Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5095Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5159Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5159Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5183Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5183Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5184Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5184Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1328Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1328Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1328Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1345Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1345Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1439Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1439Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
72189-317LOSARTAN POTASSIUMLOSARTAN POTASSIUMDirectRxANDACurrent
72189-317LOSARTAN POTASSIUMLOSARTAN POTASSIUMDirectRxANDACurrent