FDA.reportPublic FDA data

Application 209786

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL20MEQ/15MLNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL40MEQ/15MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-168potassium chloridepotassium chlorideNovel Laboratories, Inc.ANDACurrent
40032-168potassium chloridepotassium chlorideNovel Laboratories, Inc.ANDACurrent
40032-169potassium chloridepotassium chlorideNovel Laboratories, Inc.ANDACurrent
40032-169potassium chloridepotassium chlorideNovel Laboratories, Inc.ANDACurrent
43386-168POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent
43386-168POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent
43386-168POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent
43386-169POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent
43386-169POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent
43386-169POTASSIUM CHLORIDEPOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.ANDACurrent