CELLTRION FDA Approval ANDA 202266

ANDA 202266

CELLTRION

FDA Drug Application

Application #202266

Application Sponsors

ANDA 202266CELLTRION

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 75MG BASE0CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATE
002TABLET;ORALEQ 300MG BASE0CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATE

FDA Submissions

ORIG1AP2012-08-14
ORIG2AP2012-11-20
LABELING; LabelingSUPPL4AP2015-12-11STANDARD
LABELING; LabelingSUPPL5AP2020-03-24STANDARD
LABELING; LabelingSUPPL6AP2020-03-24STANDARD
LABELING; LabelingSUPPL7AP2020-03-24STANDARD
LABELING; LabelingSUPPL8AP2021-12-21STANDARD
LABELING; LabelingSUPPL9AP2022-11-28STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null7
SUPPL4Null7
SUPPL5Null7
SUPPL6Null15
SUPPL7Null15
SUPPL8Null15
SUPPL9Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CELLTRION
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202266
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2012","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/24\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-24
        )

)

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