MARKSANS PHARMA FDA Approval ANDA 215486

ANDA 215486

MARKSANS PHARMA

FDA Drug Application

Application #215486

Application Sponsors

ANDA 215486MARKSANS PHARMA

Marketing Status

Over-the-counter001

Application Products

001TABLET, EXTENDED RELEASE;ORAL650MG0ACETAMINOPHENACETAMINOPHEN

FDA Submissions

UNKNOWN; ORIG1AP2021-08-25STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215486
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"650MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-25
        )

)

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