FDA.reportPublic FDA data

Application 209744

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
42291-864TadalafilTadalafilAvKAREANDACurrent
42291-864TadalafilTadalafilAvKAREANDACurrent
42291-865TadalafilTadalafilAvKAREANDACurrent
42291-865TadalafilTadalafilAvKAREANDACurrent
42291-866TadalafilTadalafilAvKAREANDACurrent
42291-866TadalafilTadalafilAvKAREANDACurrent
42291-867TadalafilTadalafilAvKAREANDACurrent
42291-867TadalafilTadalafilAvKAREANDACurrent
60219-1346TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1347TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1348TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1349TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1346TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1346TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1346TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1346TadalafilTadalafilAmneal Pharmaceuticals LLCANDACurrent
69238-1347TadalafilTadalafilAmneal Pharmaceuticals LLCANDACurrent
69238-1347TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1347TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1347TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1348TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1348TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1348TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1348TadalafilTadalafilAmneal Pharmaceuticals LLCANDACurrent
69238-1349TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1349TadalafilTadalafilAmneal Pharmaceuticals LLCANDACurrent
69238-1349TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1349TadalafilTadalafilAmneal Pharmaceuticals NY LLCANDACurrent
70518-3001TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70518-3001TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
71335-1400TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1400TadalafilTadalafilBryant Ranch PrepackANDACurrent
71610-567TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-581TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-603TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent