FDA.reportPublic FDA data

Application 205646

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLVAPTANTOLVAPTANTABLET;ORAL30MGNoNo
002TOLVAPTANTOLVAPTANTABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-868TolvaptanTolvaptanCamber Pharmaceuticals, Inc.ANDACurrent
31722-869TolvaptanTolvaptanCamber Pharmaceuticals, Inc.ANDACurrent
31722-869TolvaptanTolvaptanCamber Pharmaceuticals, Inc.ANDACurrent