FDA.reportPublic FDA data

Application 213220

Type
ANDA
Sponsor
MSN

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
69539-130DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-131DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-132DofetilideDofetilideMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-039DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-039DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-040DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-040DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-041DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent
72205-041DofetilideDofetilideNovadoz Pharmaceuticals LLCANDACurrent