FDA.reportPublic FDA data

Application 206956

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6970TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6970TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6970TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6972TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6972TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6972TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6973TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6973TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent
0378-6973TadalafiltadalafilMylan Pharmaceuticals Inc.ANDACurrent