MICRO LABS FDA Approval ANDA 206713

ANDA 206713

MICRO LABS

FDA Drug Application

Application #206713

Documents

Letter2017-07-05

Application Sponsors

ANDA 206713MICRO LABS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0TRANEXAMIC ACIDTRANEXAMIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2017-06-27STANDARD
LABELING; LabelingSUPPL3AP2020-11-18STANDARD
LABELING; LabelingSUPPL4AP2021-06-24STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL4Null7

TE Codes

001PrescriptionAP

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206713
            [companyName] => MICRO LABS
            [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\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206713Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-04-26
        )

)

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