AUROBINDO PHARMA LTD FDA Approval ANDA 210968

ANDA 210968

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210968

Application Sponsors

ANDA 210968AUROBINDO PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR10MG/VIAL0OLANZAPINEOLANZAPINE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210968
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)

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