NDA 210865

MYLAN LABS LTD

FDA Drug Application

Application #210865

Documents

• Letter: 2019-09-12

Application Sponsors

NDA 210865

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2019-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210865
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE FUMARATE","activeIngredients":"DOLUTEGAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE FUMARATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210865Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-11
        )

)