FDA.reportPublic FDA data

Application 215323

Type
ANDA
Sponsor
VGYAAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72664-229DofetilideDofetilideVGYAAN Pharmaceuticals LLCANDACurrent
72664-230DofetilideDofetilideVGYAAN Pharmaceuticals LLCANDACurrent
72664-231DofetilideDofetilideVGYAAN Pharmaceuticals LLCANDACurrent