MYLAN PHARMS INC FDA Approval ANDA 202640

ANDA 202640

MYLAN PHARMS INC

FDA Drug Application

Application #202640

Application Sponsors

ANDA 202640MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL12.5MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
002TABLET;ORAL25MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
003TABLET;ORAL50MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2012-09-17
LABELING; LabelingSUPPL2AP2019-12-23STANDARD
LABELING; LabelingSUPPL3AP2019-12-23STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202640
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-23
        )

)

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