ANDA 204004

MYLAN PHARMS INC

FDA Drug Application

Application #204004

Application Sponsors

ANDA 204004

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

600MG;300MG

0

EPZICOM

ABACAVIR;LAMIVUDINE

FDA Submissions

ORIG

1

TA

2016-01-15

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204004
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPZICOM","activeIngredients":"ABACAVIR;LAMIVUDINE","strength":"600MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-01-15
        )

)