MACLEODS PHARMS LTD FDA Approval ANDA 203366

ANDA 203366

MACLEODS PHARMS LTD

FDA Drug Application

Application #203366

Application Sponsors

ANDA 203366MACLEODS PHARMS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 10MG BASE0MONTELUKAST SODIUMMONTELUKAST SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2014-09-11
LABELING; LabelingSUPPL7AP2018-05-18STANDARD
LABELING; LabelingSUPPL13AP2019-11-08STANDARD
LABELING; LabelingSUPPL16AP2019-11-08STANDARD
LABELING; LabelingSUPPL20AP2020-11-24STANDARD

Submissions Property Types

ORIG1Null15
SUPPL7Null7
SUPPL13Null15
SUPPL16Null7
SUPPL20Null7

TE Codes

001PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203366
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/08\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-08
        )

)

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