FDA.reportPublic FDA data

Application 214452

Type
ANDA
Sponsor
GRANULES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8399Potassium Chloride Extended-releasePotassium Chloride Extended-releaseNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8400Potassium Chloride Extended-releasePotassium Chloride Extended-releaseNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-7201Potassium Chloride Extended-releasePotassium Chloride Extended-releaseMajor PharmaceuticalsANDACurrent
0904-7202Potassium Chloride Extended-releasePotassium Chloride Extended-releaseMajor PharmaceuticalsANDACurrent
62207-726Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-726Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-727Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
62207-727Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules India LtdANDACurrent
68001-566Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBluepoint LaboratoriesANDACurrent
68001-567Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBluepoint LaboratoriesANDACurrent
68788-8196Potassium Chloride Extended-releasePotassium Chloride Extended-releasePreferred Pharmaceuticals Inc.ANDACurrent
70010-135Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-135Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-136Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70010-136Potassium Chloride Extended-releasePotassium Chloride Extended-releaseGranules Pharmaceuticals Inc.ANDACurrent
70518-3521Potassium Chloride Extended-releasePotassium Chloride Extended-releaseREMEDYREPACK INC.ANDACurrent
70518-3521Potassium Chloride Extended-releasePotassium Chloride Extended-releaseREMEDYREPACK INC.ANDACurrent
71335-1896Potassium Chloride Extended-releasePotassium Chloride Extended-releaseBryant Ranch PrepackANDACurrent