FDA.reportPublic FDA data

Application 209654

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-111TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-111TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-111TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-111TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-111TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-111TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-112TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-112TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-112TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-112TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-112TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-112TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-113TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-113TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-113TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-113TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-113TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-113TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-114TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-114TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-114TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-114TadalafilTadalafilAjanta Pharma USA Inc.ANDACurrent
27241-114TadalafilTadalafilAjanta Pharma LimitedANDACurrent
27241-114TadalafilTadalafilAjanta Pharma LimitedANDACurrent
50090-5344TadalafilTadalafilA-S Medication SolutionsANDACurrent
50090-5641TadalafilTadalafilA-S Medication SolutionsANDACurrent
50436-0114TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-1120TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-1120TadalafilTadalafilUnit Dose ServicesANDACurrent
63629-8288TadalafilTadalafilBryant Ranch PrepackANDACurrent
63629-8288TadalafilTadalafilBryant Ranch PrepackANDACurrent
68071-2417TadalafilTadalafilNUCARE PHARMACEUTICALS INCANDACurrent
68071-2417TadalafilTadalafilNUCARE PHARMACEUTICALS INCANDACurrent
68071-2421TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2421TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2421TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2421TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2451TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2554TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2613TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2632TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8292TadalafilTadalafilPreferred Pharmaceuticals Inc.ANDACurrent
70518-3434TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70518-3434TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70518-3434TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
71205-734TadalafilTadalafilProficient Rx LPANDACurrent
71205-735TadalafilTadalafilProficient Rx LPANDACurrent
71205-736TadalafilTadalafilProficient Rx LPANDACurrent
71335-1491TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1491TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1491TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1670TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1670TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1670TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1823TadalafilTadalafilBryant Ranch PrepackANDACurrent
71610-461TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-145TADALAFILTADALAFILdirect rxANDACurrent
72789-184TadalafilTadalafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-184TadalafilTadalafilPD-Rx Pharmaceuticals, Inc.ANDACurrent