NDA 213556

SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

FDA Drug Application

Application #213556

Documents

• Letter: 2020-10-07

Application Sponsors

NDA 213556

SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

50MG; 300MG; 300MG

0

DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2020-10-06

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213556
            [companyName] => SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR, LAMIVUDINE AND 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":"10\/06\/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\\\/213556Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-06
        )

)