AUROMEDICS PHARMA LLC FDA Approval ANDA 213672

ANDA 213672

AUROMEDICS PHARMA LLC

FDA Drug Application

Application #213672

Application Sponsors

ANDA 213672AUROMEDICS PHARMA LLC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-07-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AUROMEDICS PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213672
            [companyName] => AUROMEDICS PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PLERIXAFOR","activeIngredients":"PLERIXAFOR","strength":"24MG\/1.2ML(20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-19
        )

)

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