FDA.reportPublic FDA data

Application 212835

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROXIDOPADROXIDOPACAPSULE;ORAL100MGNoNo
002DROXIDOPADROXIDOPACAPSULE;ORAL200MGNoNo
003DROXIDOPADROXIDOPACAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0532DroxidopaDroxidopaHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0533DroxidopaDroxidopaHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0534DroxidopaDroxidopaHikma Pharmaceuticals USA Inc.ANDACurrent