APOTEX INC FDA Approval ANDA 090798

ANDA 090798

APOTEX INC

FDA Drug Application

Application #090798

Documents

Letter2012-04-25

Application Sponsors

ANDA 090798APOTEX INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

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

FDA Submissions

ORIG1AP2012-04-23

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90798
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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