FDA.reportPublic FDA data

Application 206347

Type
ANDA
Sponsor
NOVEL LABS INC

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
0615-8336Potassium ChloridePotassium ChlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8336Potassium ChloridePotassium ChlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8336Potassium ChloridePotassium ChlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8337Potassium ChloridePotassium ChlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8337Potassium ChloridePotassium ChlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-7085Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
0904-7086Potassium ChloridePotassium ChlorideMajor PharmaceuticalsANDACurrent
40032-915Potassium ChloridePotassium ChlorideNovel Laboratories, Inc.ANDACurrent
40032-915Potassium ChloridePotassium ChlorideNovel Laboratories, Inc.ANDACurrent
40032-917Potassium ChloridePotassium ChlorideNovel Laboratories, Inc.ANDACurrent
40032-917Potassium ChloridePotassium ChlorideNovel Laboratories, Inc.ANDACurrent
43386-915Potassium ChloridePotassium ChlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-915Potassium ChloridePotassium ChlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-917Potassium ChloridePotassium ChlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-917Potassium ChloridePotassium ChlorideLupin Pharmaceuticals,Inc.ANDACurrent
55154-4158Potassium ChloridePotassium ChlorideCardinal Health 107, LLCANDACurrent
70934-639Potassium ChloridePotassium ChlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent