FDA.reportPublic FDA data

Application 207759

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEVELAMER CARBONATESEVELAMER CARBONATETABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-824Sevelamer carbonateSevelamer carbonateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-824Sevelamer carbonateSevelamer carbonateZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1520Sevelamer carbonateSevelamer carbonateZydus Lifesciences LimitedANDACurrent
70771-1520Sevelamer carbonateSevelamer carbonateCadila Healthcare LimitedANDACurrent