MYLAN LABS LTD FDA Approval ANDA 207595

ANDA 207595

MYLAN LABS LTD

FDA Drug Application

Application #207595

Application Sponsors

ANDA 207595MYLAN LABS LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION10MG/ML0NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDE
002INJECTABLE;INJECTION20MG/ML0NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-01-11STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

MYLAN LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207595
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALBUPHINE HYDROCHLORIDE","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NALBUPHINE HYDROCHLORIDE","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/10\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-10
        )

)

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