AM REGENT FDA Approval ANDA 201885

ANDA 201885

AM REGENT

FDA Drug Application

Application #201885

Application Sponsors

ANDA 201885AM REGENT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0TRANEXAMIC ACIDTRANEXAMIC ACID

FDA Submissions

N/A; Not ApplicableORIG1AP2011-08-10
LABELING; LabelingSUPPL2AP2015-12-21STANDARD
LABELING; LabelingSUPPL3AP2015-12-21STANDARD
LABELING; LabelingSUPPL6AP2019-03-06STANDARD
LABELING; LabelingSUPPL7AP2021-01-25STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL6Null15
SUPPL7Null7

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201885
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANEXAMIC ACID","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/25\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/06\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-25
        )

)

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