NDA 210540

MYLAN LABS LTD

FDA Drug Application

Application #210540

Documents

• Letter: 2018-08-20

Application Sponsors

NDA 210540

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2018-08-16

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210540
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR; RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210540Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-16
        )

)