FDA.reportPublic FDA data

Application 210466

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOFETILIDEDOFETILIDECAPSULE;ORAL0.125MGNoNo
002DOFETILIDEDOFETILIDECAPSULE;ORAL0.25MGNoNo
003DOFETILIDEDOFETILIDECAPSULE;ORAL0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-061DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-062DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-063DOFETILIDEDOFETILIDESun Pharmaceutical Industries, Inc.ANDACurrent