MACLEODS PHARMS LTD FDA Approval ANDA 203044

ANDA 203044

MACLEODS PHARMS LTD

FDA Drug Application

Application #203044

Application Sponsors

ANDA 203044MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL5MG0OLANZAPINEOLANZAPINE
002TABLET, ORALLY DISINTEGRATING;ORAL10MG0OLANZAPINEOLANZAPINE
003TABLET, ORALLY DISINTEGRATING;ORAL15MG0OLANZAPINEOLANZAPINE
004TABLET, ORALLY DISINTEGRATING;ORAL20MG0OLANZAPINEOLANZAPINE

FDA Submissions

UNKNOWN; ORIG1AP2015-02-20
LABELING; LabelingSUPPL3AP2015-11-27STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203044
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-27
        )

)

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