FDA.reportPublic FDA data

Application 214391

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
27241-199DroxidopaDroxidopaAjanta Pharma LimitedANDACurrent
27241-199DroxidopaDroxidopaAjanta Pharma USA Inc.ANDACurrent
27241-200DroxidopaDroxidopaAjanta Pharma LimitedANDACurrent
27241-200DroxidopaDroxidopaAjanta Pharma USA Inc.ANDACurrent
27241-201DroxidopaDroxidopaAjanta Pharma LimitedANDACurrent
27241-201DroxidopaDroxidopaAjanta Pharma USA Inc.ANDACurrent