RUBICON FDA Approval ANDA 215725

ANDA 215725

RUBICON

FDA Drug Application

Application #215725

Application Sponsors

ANDA 215725RUBICON

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE
002TABLET, EXTENDED RELEASE;ORAL20MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB3
002PrescriptionAB3

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215725
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-25
        )

)

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