NDA 214544

LUPIN LTD

FDA Drug Application

Application #214544

Documents

• Letter: 2023-01-20

Application Sponsors

NDA 214544

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2023-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214544
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE","activeIngredients":"DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE","strength":"50MG;200MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2023","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\\\/2023\\\/214544Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-19
        )

)