AJANTA PHARMA LTD FDA Approval ANDA 206711

ANDA 206711

AJANTA PHARMA LTD

FDA Drug Application

Application #206711

Application Sponsors

ANDA 206711AJANTA PHARMA LTD

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; ORIG1AP2016-08-30STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206711
            [companyName] => AJANTA PHARMA LTD
            [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":"08\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-30
        )

)

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