TEVA PHARMS USA INC FDA Approval ANDA 211094

ANDA 211094

TEVA PHARMS USA INC

FDA Drug Application

Application #211094

Application Sponsors

ANDA 211094TEVA PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

002TABLET;ORAL50MG0DASATINIBDASATINIB
003TABLET;ORAL70MG0DASATINIBDASATINIB
004TABLET;ORAL80MG0DASATINIBDASATINIB
005TABLET;ORAL100MG0DASATINIBDASATINIB
006TABLET;ORAL140MG0DASATINIBDASATINIB

FDA Submissions

UNKNOWN; ORIG1TA2022-07-01STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211094
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"70MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-01
        )

)

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