SUNSHINE FDA Approval ANDA 214748

ANDA 214748

SUNSHINE

FDA Drug Application

Application #214748

Application Sponsors

ANDA 214748SUNSHINE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET;ORAL10MG0BRIVARACETAMBRIVARACETAM
002TABLET;ORAL25MG0BRIVARACETAMBRIVARACETAM
003TABLET;ORAL50MG0BRIVARACETAMBRIVARACETAM
004TABLET;ORAL75MG0BRIVARACETAMBRIVARACETAM
005TABLET;ORAL100MG0BRIVARACETAMBRIVARACETAM

FDA Submissions

UNKNOWN; ORIG1AP2022-06-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

SUNSHINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214748
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)

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