AMNEAL PHARMS FDA Approval ANDA 210042

ANDA 210042

AMNEAL PHARMS

FDA Drug Application

Application #210042

Application Sponsors

ANDA 210042AMNEAL PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2022-06-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210042
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-22
        )

)

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