FDA.reportPublic FDA data

Application 212861

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL15MEQNoNo
003POTASSIUM CHLORIDEPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5665Potassium ChloridePotassium ChlorideA-S Medication SolutionsANDACurrent
60219-1065Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1065Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1067Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1067Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1069Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1069Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1065Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1065Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1065Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1067Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1067Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1067Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1069Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1069Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1069Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-3525Potassium ChloridePotassium ChlorideREMEDYREPACK INC.ANDACurrent
72789-239Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent