AKORN FDA Approval ANDA 206634

ANDA 206634

AKORN

FDA Drug Application

Application #206634

Application Sponsors

ANDA 206634AKORN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0TRANEXAMIC ACIDTRANEXAMIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2016-06-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206634
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-14
        )

)

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