QILU FDA Approval ANDA 212135

ANDA 212135

QILU

FDA Drug Application

Application #212135

Application Sponsors

ANDA 212135QILU

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1TA2022-02-11STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

QILU
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212135
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-11
        )

)

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