ANDA 207595

MYLAN LABS LTD

FDA Drug Application

Application #207595

Application Sponsors

ANDA 207595

MYLAN LABS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	10MG/ML	0	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	20MG/ML	0	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

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
        )

)