RUBICON FDA Approval ANDA 214108

ANDA 214108

RUBICON

FDA Drug Application

Application #214108

Application Sponsors

ANDA 214108RUBICON

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL20MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214108
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-24
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.