WINDER LABS LLC FDA Approval ANDA 211362

ANDA 211362

WINDER LABS LLC

FDA Drug Application

Application #211362

Application Sponsors

ANDA 211362WINDER LABS LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL0.025MG;2.5MG0DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

WINDER LABS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211362
            [companyName] => WINDER LABS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"0.025MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-27
        )

)

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