ANDA 208452

MYLAN PHARMS INC

FDA Drug Application

Application #208452

Documents

• Letter: 2017-12-18

Application Sponsors

ANDA 208452

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

200MG;25MG;300MG

0

EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208452
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE;RILPIVIRINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG;25MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208452Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-20
        )

)