MYLAN FDA Approval ANDA 213255

ANDA 213255

MYLAN

FDA Drug Application

Application #213255

Application Sponsors

ANDA 213255MYLAN

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)0ACETAMINOPHENACETAMINOPHEN

FDA Submissions

UNKNOWN; ORIG1AP2020-08-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213255
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"1GM\/100ML (10MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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