FDA.reportPublic FDA data

Application 205995

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACAMPROSATE CALCIUMACAMPROSATE CALCIUMTABLET, DELAYED RELEASE;ORAL333MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-569acamprosate calciumacamprosate calciumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-569acamprosate calciumacamprosate calciumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-569acamprosate calciumacamprosate calciumZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1057acamprosate calciumacamprosate calciumCadila Healthcare LimitedANDACurrent
70771-1057acamprosate calciumacamprosate calciumCadila Healthcare LimitedANDACurrent
70771-1057acamprosate calciumacamprosate calciumCadila Healthcare LimitedANDACurrent