FDA.reportPublic FDA data

Application 208445

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL8MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MEQNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-853potassium chloridepotassium chlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-853potassium chloridepotassium chlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-854potassium chloridepotassium chlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-854potassium chloridepotassium chlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent