MYLAN PHARMS INC FDA Approval ANDA 202778

ANDA 202778

MYLAN PHARMS INC

FDA Drug Application

Application #202778

Application Sponsors

ANDA 202778MYLAN PHARMS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 150MG BASE0DOXYCYCLINEDOXYCYCLINE

FDA Submissions

UNKNOWN; ORIG1AP2012-06-08
LABELING; LabelingSUPPL3AP2014-06-17STANDARD
LABELING; LabelingSUPPL4AP2014-11-26STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL4Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202778
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/26\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-11-26
        )

)

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