NDA 213681

LAURUS LABS LTD

FDA Drug Application

Application #213681

Documents

• Letter: 2020-12-08

Application Sponsors

NDA 213681

LAURUS LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2020-12-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213681
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE","activeIngredients":"DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2020","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\\\/2020\\\/213681Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-04
        )

)