FDA.reportPublic FDA data

Application 210392

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-123TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-123TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-123TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-123TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-123TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent