FDA.reportPublic FDA data

Application 211060

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILODOSINSILODOSINCAPSULE;ORAL4MGNoNo
002SILODOSINSILODOSINCAPSULE;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-144SilodosinSilodosinAjanta Pharma LimitedANDACurrent
27241-144SilodosinSilodosinAjanta Pharma LimitedANDACurrent
27241-144SilodosinSilodosinAjanta Pharma USA Inc.ANDACurrent
27241-144SilodosinSilodosinAjanta Pharma LimitedANDACurrent
27241-145SilodosinSilodosinAjanta Pharma LimitedANDACurrent
27241-145SilodosinSilodosinAjanta Pharma LimitedANDACurrent
27241-145SilodosinSilodosinAjanta Pharma USA Inc.ANDACurrent
27241-145SilodosinSilodosinAjanta Pharma LimitedANDACurrent