ANDA 208594

MYLAN PHARMS INC

FDA Drug Application

Application #208594

Application Sponsors

ANDA 208594

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-12-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208594
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLNALTREXONE BROMIDE","activeIngredients":"METHYLNALTREXONE BROMIDE","strength":"8MG\/0.4ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"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":"12\/21\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)