AMNEAL PHARMS LLC FDA Approval ANDA 209951

ANDA 209951

AMNEAL PHARMS LLC

FDA Drug Application

Application #209951

Application Sponsors

ANDA 209951AMNEAL PHARMS LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL48MG0FENOFIBRATEFENOFIBRATE
002TABLET;ORAL145MG0FENOFIBRATEFENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2018-02-09STANDARD
LABELING; LabelingSUPPL2AP2019-09-23STANDARD
LABELING; LabelingSUPPL3AP2019-09-23STANDARD
LABELING; LabelingSUPPL5AP2022-04-05STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15
SUPPL5Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209951
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-23
        )

)

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