MYLAN PHARMS INC FDA Approval ANDA 202581

ANDA 202581

MYLAN PHARMS INC

FDA Drug Application

Application #202581

Application Sponsors

ANDA 202581MYLAN PHARMS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL324MG0QUININE SULFATEQUININE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2012-12-14
LABELING; LabelingSUPPL3AP2013-07-11STANDARD
LABELING; LabelingSUPPL4AP2015-12-04STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null15
SUPPL4Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202581
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUININE SULFATE","activeIngredients":"QUININE SULFATE","strength":"324MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/04\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/11\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-04
        )

)

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