WINDER LABS LLC FDA Approval ANDA 211454

ANDA 211454

WINDER LABS LLC

FDA Drug Application

Application #211454

Application Sponsors

ANDA 211454WINDER LABS LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;ORAL10MG/5ML0MORPHINE SULFATEMORPHINE SULFATE
002SOLUTION;ORAL20MG/5ML0MORPHINE SULFATEMORPHINE SULFATE
003SOLUTION;ORAL100MG/5ML0MORPHINE SULFATEMORPHINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

WINDER LABS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211454
            [companyName] => WINDER LABS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-12
        )

)

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