SUNSHINE FDA Approval ANDA 214004

ANDA 214004

SUNSHINE

FDA Drug Application

Application #214004

Application Sponsors

ANDA 214004SUNSHINE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
002TABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
003TABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUNSHINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214004
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)

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