FDA.reportPublic FDA data

Application 074726

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLOR-CON M20POTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQNoYes
002KLOR-CON M10POTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQNoNo
003KLOR-CON M15POTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL15MEQNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0057Klor-Con MPotassium ChlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0058Klor-Con MPotassium ChlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0150Klor-Con MPotassium ChlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-5317KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5317KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5317KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5317KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5318KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5318KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5318KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5318KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5319KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5319KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5319KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-5319KLOR-CON Mpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0615-3599Klor Con Mpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5559Klor Con Mpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7861KLOR-CON MPotassium ChlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7862KLOR-CON Mpotassium chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-5710Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0781-5710Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0781-5710Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0781-5720Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0781-5720Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0781-5720Potassium ChloridePotassium ChlorideSandoz IncANDACurrent
0832-5324Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
0832-5324Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
0832-5324Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
0832-5325Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
0832-5325Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
0832-5325Potassium Chloridepotassium chlorideUpsher-SmithLaboratories, LLCANDACurrent
42291-507Potassium Chloridepotassium chlorideAvKARE, IncANDACurrent
42291-507Potassium Chloridepotassium chlorideAvKAREANDACurrent
42291-507Potassium Chloridepotassium chlorideAvKAREANDACurrent
43063-829Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-829Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-829Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-984Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-984Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-984Potassium ChloridePotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-797Klor-Con MPotassium ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-988KLOR-CON Mpotassium chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-990KLOR-CON Mpotassium chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
48433-322Potassium ChloridePotassium ChlorideSafecor Health, LLCANDACurrent
48433-323Potassium ChloridePotassium ChlorideSafecor Health, LLCANDACurrent
50090-0794Potassium ChloridePotassium ChlorideA-S Medication SolutionsANDACurrent
50090-2257Potassium ChloridePotassium ChlorideA-S Medication SolutionsANDACurrent
50090-2257Potassium ChloridePotassium ChlorideA-S Medication SolutionsANDACurrent
50090-5612KLOR-CON M20potassium chlorideA-S Medication SolutionsANDACurrent
50436-4311Potassium ChloridePotassium ChlorideUnit Dose ServicesANDACurrent
55154-0926KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-0926KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-0926KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-0928KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-0928KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-0928KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-1478Potassium ChloridePotassium ChlorideCardinal HealthANDACurrent
55154-1478Potassium ChloridePotassium ChlorideCardinal HealthANDACurrent
55154-1478Potassium ChloridePotassium ChlorideCardinal HealthANDACurrent
55154-5634KLOR-CON Mpotassium chlorideCardinal Health 107, LLCANDACurrent
55154-5634KLOR-CON Mpotassium chlorideCardinal HealthANDACurrent
55154-8135Potassium ChloridePotassium ChlorideCardinal HealthANDACurrent
55289-444Klor-Con MPotassium ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-6430Potassium ChloridePotassium ChlorideBryant Ranch PrepackANDACurrent
63629-6430Potassium ChloridePotassium ChlorideBryant Ranch PrepackANDACurrent
63629-6534KLOR-CON Mpotassium chlorideBryant Ranch PrepackANDACurrent
63629-6534KLOR-CON Mpotassium chlorideBryant Ranch PrepackANDACurrent
63739-446Potassium ChloridePotassium ChlorideMcKesson Packaging Services Business Unit of McKesson CorporationANDACurrent
63739-447Potassium ChloridePotassium ChlorideMcKesson Packaging Services Business Unit of McKesson CorporationANDACurrent
63739-972Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-972Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-972Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-972Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-973Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-973Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-973Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
63739-973Potassium Chloridepotassium chlorideMckesson Corporation DBA SKY PackaginngANDACurrent
66758-170KLOR-CON Mpotassium chlorideSandoz Inc.ANDACurrent
66758-170KLOR-CON Mpotassium chlorideSandoz Inc.ANDACurrent
66758-170KLOR-CON Mpotassium chlorideSandoz Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42864SUPPL2016-02-03
42863SUPPL2016-02-03
42862SUPPL2016-02-03
22355SUPPL2016-02-03
18363ORIG2004-06-07
22354ORIG2003-08-01
8437ORIG1998-11-20