FDA.reportPublic FDA data

Application 019123

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLOR-CONPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL8MEQYesNo
002KLOR-CONPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0040Klor-ConPotassium ChlorideUpsher-Smith Laboratories, Inc.NDACurrent
0245-0041Klor-ConPotassium ChlorideUpsher-Smith Laboratories, Inc.NDACurrent
0245-5315KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5315Potassium Chloridepotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5315KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5315Potassium Chloridepotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5315KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5316KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5316KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5316Potassium Chloridepotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5316KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0245-5316Potassium Chloridepotassium chlorideUpsher-Smith Laboratories, LLCNDACurrent
0440-8110Klor-ConPotassium ChlorideLiberty Pharmaceuticals, Inc.NDACurrent
0440-8110Klor-ConPotassium ChlorideLiberty Pharmaceuticals, Inc.NDACurrent
0615-8045KLOR-CONpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0615-8045KLOR-CONpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0615-8045KLOR-CONpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0615-8318Potassium Chloridepotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0781-1516Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1516Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1516Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1516Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1526Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1526Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1526Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0781-1526Potassium ChloridePotassium ChlorideSandoz Inc.NDACurrent
0832-5322Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5322Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5322Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5322Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5323Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5323Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5323Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
0832-5323Potassium ChloridePotassium ChlorideUpsher-Smith Laboratories, LLCNDACurrent
33261-215Potassium ChloridePotassium ChlorideAidarex Pharmaceuticals LLCNDACurrent
42291-506Potassium ChloridePotassium ChlorideAvKARE, IncNDACurrent
42291-506Potassium ChloridePotassium ChlorideAvKARENDACurrent
42291-506Potassium ChloridePotassium ChlorideAvKARENDACurrent
43353-064KLOR-CONpotassium chlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-064KLOR-CONpotassium chlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
53002-1034Potassium ChloridePotassium ChlorideRPK Pharmaceuticals, Inc.NDACurrent
53002-1034Potassium ChloridePotassium ChlorideRPK Pharmaceuticals, Inc.NDACurrent
53808-0278Klor-ConPotassium ChlorideState of Florida DOH Central PharmacyNDACurrent
53808-0375Klor-ConPotassium ChlorideState of Florida DOH Central PharmacyNDACurrent
55154-0927KLOR-CONpotassium chlorideCardinal HealthNDACurrent
55154-0927KLOR-CONpotassium chlorideCardinal HealthNDACurrent
55154-0927KLOR-CONpotassium chlorideCardinal HealthNDACurrent
55289-697Klor-ConPotassium ChloridePD-Rx Pharmaceuticals, Inc.NDACurrent
58118-1526Potassium ChloridePotassium ChlorideClinical Solutions WholesaleNDACurrent
58118-1526Potassium ChloridePotassium ChlorideClinical Solutions WholesaleNDACurrent
58118-1526Potassium ChloridePotassium ChlorideClinical Solutions WholesaleNDACurrent
63187-979Potassium ChloridePotassium ChlorideProficient Rx LPNDACurrent
63187-979Potassium ChloridePotassium ChlorideProficient Rx LPNDACurrent
63629-2937Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDACurrent
65084-464KLOR-CONpotassium chlorideMckesson Rxpak IncNDACurrent
65084-465KLOR-CONpotassium chlorideMckesson Rxpak IncNDACurrent
66758-110KLOR-CONpotassium chlorideSandoz Inc.NDACurrent
66758-110KLOR-CONpotassium chlorideSandoz Inc.NDACurrent
66758-160KLOR-CONpotassium chlorideSandoz Inc.NDACurrent
66758-160KLOR-CONpotassium chlorideSandoz Inc.NDACurrent
67046-350Klor-ConPotassium ChlorideContract Pharmacy Services-PANDACurrent
67296-1653Potassium ChloridePotassium ChlorideRedPharm Drug, Inc.NDACurrent
67296-1653Potassium ChloridePotassium ChlorideRedPharm Drug, Inc.NDACurrent
67544-154Klor-ConPotassium ChlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-237Klor-ConPotassium ChlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
68071-4296Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.NDACurrent
68071-4296Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.NDACurrent
68071-4708Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.NDACurrent
68071-4708Potassium ChloridePotassium ChlorideNuCare Pharmaceuticals,Inc.NDACurrent
70518-0057Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDACurrent
70518-0057Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDACurrent
70518-2313Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDACurrent
70518-2313Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDACurrent
70518-2313Potassium ChloridePotassium ChlorideREMEDYREPACK INC.NDACurrent
70934-340Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent
70934-340Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent
70934-451Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent
70934-451Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent
70934-451Potassium ChloridePotassium ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDACurrent
71335-0763Potassium ChloridePotassium ChlorideBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53989SUPPL2018-05-03
53980SUPPL2018-05-02
52716SUPPL2018-02-26
40875ORIG2010-03-16
16199SUPPL2006-04-20
16198SUPPL2004-05-27
1230SUPPL2003-11-25