FDA.reportPublic FDA data

Application 018279

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQYesNo
002K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL8MEQYesNo
003K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3023K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3023K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3023K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3058K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3058K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3058K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3278K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3278K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-3278K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-7804K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0074-7804K-TabPotassium ChlorideAbbVie Inc.NDACurrent
0904-6507Potassium ChloridePotassium ChlorideMajor PharmaceuticalsNDA AUTHORIZED GENERICCurrent
10544-565Potassium ChloridePotassium ChlorideBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
43353-790K-TabPotassium ChlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-1326Potassium ChloridePotassium ChlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-1326Potassium ChloridePotassium ChlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2113Potassium ChloridePotassium ChlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4285Potassium ChloridePotassium ChlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4285Potassium ChloridePotassium ChlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
51655-587Potassium ChloridePotassium Chloride ERNorthwind PharmaceuticalsNDACurrent
53808-0277K-TABPOTASSIUM CHLORIDEState of Florida DOH Central PharmacyNDACurrent
60687-466Potassium ChloridePotassium ChlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-466Potassium ChloridePotassium ChlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60760-293Potassium ChloridePotassium ChlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-600Potassium ChloridePotassium ChlorideSt Marys Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-600Potassium ChloridePotassium ChlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
61919-445POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDIRECT RXNDACurrent
61919-445POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDIRECT RXNDACurrent
61919-953POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
61919-953POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
63187-610Potassium ChloridePotassium ChlorideProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-610Potassium ChloridePotassium ChlorideProficient Rx LPNDA AUTHORIZED GENERICCurrent
64725-0600Potassium ChloridePotassium ChlorideTYA PharmaceuticalsNDA AUTHORIZED GENERICCurrent
66267-259Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66267-259Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66267-259Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68084-524Potassium ChloridePotassium ChlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-524Potassium ChloridePotassium ChlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68084-524Potassium ChloridePotassium ChlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
68382-320Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-320Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-320Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-398Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-398Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-398Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-600Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-600Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-600Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-776Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-776Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-776Potassium ChloridePotassium ChlorideZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68788-6771Potassium ChloridePotassium ChloridePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-6771Potassium ChloridePotassium ChloridePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7748Potassium ChloridePotassium ChloridePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7748Potassium ChloridePotassium ChloridePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7748Potassium ChloridePotassium ChloridePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-0220K-TabPotassium ChlorideREMEDYREPACK INC.NDACurrent
70518-1188Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1188Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71335-1050Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1050Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1050Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1210Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1210Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1315Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1315Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54050SUPPL2018-05-08
53988SUPPL2018-05-03
11191SUPPL2014-07-03
11190SUPPL2013-11-26
887SUPPL2012-02-17
14964SUPPL2004-12-30