NDA 211912

CELLTRION INC

FDA Drug Application

Application #211912

Documents

• Letter: 2020-04-14

Application Sponsors

NDA 211912

CELLTRION INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2020-04-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CELLTRION INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211912
            [companyName] => CELLTRION INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"50MG;300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/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\\\/211912Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-13
        )

)