TEVA PHARMS USA FDA Approval ANDA 204285

ANDA 204285

TEVA PHARMS USA

FDA Drug Application

Application #204285

Application Sponsors

ANDA 204285TEVA PHARMS USA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 100MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE
002TABLET;ORALEQ 400MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2016-08-04
LABELING; LabelingSUPPL2AP2020-01-09STANDARD
LABELING; LabelingSUPPL3AP2020-01-09STANDARD
LABELING; LabelingSUPPL4AP2020-01-09STANDARD
LABELING; LabelingSUPPL5AP2020-01-09STANDARD
LABELING; LabelingSUPPL7AP2020-01-09STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7
SUPPL5Null7
SUPPL7Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204285
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/09\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-09
        )

)

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