NDA 212303

LUPIN PHARMS

FDA Drug Application

Application #212303

Documents

• Letter: 2021-06-29

Application Sponsors

NDA 212303

LUPIN PHARMS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

50MG; 300MG; 300MG

0

Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate

Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2021-06-25

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212303
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate","activeIngredients":"Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate","strength":"50MG; 300MG; 300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2021","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\\\/2021\\\/212303Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-25
        )

)