MYLAN PHARMS INC FDA Approval ANDA 200475

ANDA 200475

MYLAN PHARMS INC

FDA Drug Application

Application #200475

Application Sponsors

ANDA 200475MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0LEVETIRACETAMLEVETIRACETAM
002TABLET, EXTENDED RELEASE;ORAL750MG0LEVETIRACETAMLEVETIRACETAM
003TABLET, EXTENDED RELEASE;ORAL1GM0LEVETIRACETAMLEVETIRACETAM

FDA Submissions

N/A; Not ApplicableORIG1AP2011-12-19
LABELING; LabelingSUPPL4AP2014-03-18STANDARD
LABELING; LabelingSUPPL6AP2021-01-29STANDARD
LABELING; LabelingSUPPL7AP2021-01-29STANDARD
LABELING; LabelingSUPPL8AP2021-01-29STANDARD
LABELING; LabelingSUPPL9AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15
SUPPL6Null7
SUPPL7Null7
SUPPL8Null7
SUPPL9Null15

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200475
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/18\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-03-18
        )

)

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