STRIDES PHARMA FDA Approval ANDA 210011

ANDA 210011

STRIDES PHARMA

FDA Drug Application

Application #210011

Application Sponsors

ANDA 210011STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG0ALBENDAZOLEALBENDAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-07STANDARD
LABELING; LabelingSUPPL2AP2020-03-15STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210011
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-15
        )

)

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