FDA.reportPublic FDA data

Application 202128

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MEQNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-671Potassium ChloridePotassium ChlorideAvPAKANDACurrent
50268-671Potassium ChloridePotassium ChlorideAvPAKANDACurrent
53746-542Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-542Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-542Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-542Potassium ChloridePotassium ChlorideAmneal Pharmaceuticals of New York LLCANDACurrent
60687-310Potassium ChloridePotassium ChlorideAmerican Health PackagingANDACurrent
60687-310Potassium ChloridePotassium ChlorideAmerican Health PackagingANDACurrent
65162-542Potassium ChloridePotassium ChlorideAmneal PharmaceuticalsANDACurrent
68001-259Potassium ChloridePotassium ChlorideBluePoint LaboratoriesANDACurrent