NDA 214521

MYLAN LABS LTD

FDA Drug Application

Application #214521

Documents

• Letter: 2020-11-23

Application Sponsors

NDA 214521

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2020-11-19

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214521
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR","activeIngredients":"DOLUTEGRAVIR","strength":"UNKOWN","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214521Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-19
        )

)