MACLEODS PHARMS LTD FDA Approval ANDA 203772

ANDA 203772

MACLEODS PHARMS LTD

FDA Drug Application

Application #203772

Application Sponsors

ANDA 203772MACLEODS PHARMS LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL2.5MG0ZOLMITRIPTANZOLMITRIPTAN
002TABLET;ORAL5MG0ZOLMITRIPTANZOLMITRIPTAN

FDA Submissions

UNKNOWN; ORIG1AP2015-09-30
LABELING; LabelingSUPPL11AP2020-03-16STANDARD

Submissions Property Types

ORIG1Null7
SUPPL11Null7

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203772
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-16
        )

)

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