FDA.reportPublic FDA data

Application 207746

Type
ANDA
Sponsor
SIGMAPHARM LABS LLC

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
42291-411DofetilideDofetilideAvKAREANDACurrent
42291-411DofetilideDofetilideAvKAREANDACurrent
42291-411DofetilideDofetilideAvKAREANDACurrent
42291-411DofetilideDofetilideAvKARE, Inc.ANDACurrent
42291-412DofetilideDofetilideAvKARE, Inc.ANDACurrent
42291-412DofetilideDofetilideAvKAREANDACurrent
42291-412DofetilideDofetilideAvKAREANDACurrent
42291-412DofetilideDofetilideAvKAREANDACurrent
42291-413DofetilideDofetilideAvKARE, Inc.ANDACurrent
42291-413DofetilideDofetilideAvKAREANDACurrent
42291-413DofetilideDofetilideAvKAREANDACurrent
42291-413DofetilideDofetilideAvKAREANDACurrent
42794-044DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-044DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-044DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-044DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-045DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-045DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-045DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-045DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-046DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-046DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-046DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent
42794-046DofetilideDofetilideSigmapharm Laboratories, LLCANDACurrent