AXAR PHARMA INC FDA Approval ANDA 213762

ANDA 213762

AXAR PHARMA INC

FDA Drug Application

Application #213762

Application Sponsors

ANDA 213762AXAR PHARMA INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2021-02-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AXAR PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213762
            [companyName] => AXAR PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARFORMOTEROL TARTRATE","activeIngredients":"ARFORMOTEROL TARTRATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-03
        )

)

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