ANDA 208592

MYLAN LABS LTD

FDA Drug Application

Application #208592

Documents

• Letter: 2017-06-06

Application Sponsors

ANDA 208592

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

12MG/0.6ML

0

METHYLNALTREXONE BROMIDE

METHYLNALTREXONE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208592
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLNALTREXONE BROMIDE","activeIngredients":"METHYLNALTREXONE BROMIDE","strength":"12MG\/0.6ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208592Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-03
        )

)