SUNSHINE LAKE FDA Approval ANDA 206238

ANDA 206238

SUNSHINE LAKE

FDA Drug Application

Application #206238

Application Sponsors

ANDA 206238SUNSHINE LAKE

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

001TABLET;ORAL2.5MG0OLANZAPINEOLANZAPINE
002TABLET;ORAL5MG0OLANZAPINEOLANZAPINE
003TABLET;ORAL7.5MG0OLANZAPINEOLANZAPINE
004TABLET;ORAL10MG0OLANZAPINEOLANZAPINE
005TABLET;ORAL15MG0OLANZAPINEOLANZAPINE
006TABLET;ORAL20MG0OLANZAPINEOLANZAPINE

FDA Submissions

UNKNOWN; ORIG1AP2018-11-19STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

SUNSHINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206238
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-19
        )

)

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