GLAND PHARMA LTD FDA Approval ANDA 207239

ANDA 207239

GLAND PHARMA LTD

FDA Drug Application

Application #207239

Application Sponsors

ANDA 207239GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0TRANEXAMIC ACIDTRANEXAMIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2017-02-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207239
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/13\/2017","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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