RUBICON FDA Approval ANDA 211953

ANDA 211953

RUBICON

FDA Drug Application

Application #211953

Application Sponsors

ANDA 211953RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL100MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
002TABLET;ORAL200MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
003TABLET;ORAL300MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211953
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-18
        )

)

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