STRIDES PHARMA FDA Approval ANDA 214071

ANDA 214071

STRIDES PHARMA

FDA Drug Application

Application #214071

Application Sponsors

ANDA 214071STRIDES PHARMA

Marketing Status

Over-the-counter001

Application Products

001SUSPENSION/DROPS;ORAL50MG/1.25ML0IBUPROFENIBUPROFEN

FDA Submissions

UNKNOWN; ORIG1AP2022-06-09STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214071
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"50MG\/1.25ML","dosageForm":"SUSPENSION\/DROPS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)

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