NDA 212527

CIPLA USA INC.

FDA Drug Application

Application #212527

Documents

• Letter: 2022-03-31

Application Sponsors

NDA 212527

CIPLA USA INC.

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION; ORAL

EQ 50MG BASE; 300MG; 25MG

0

DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2022-03-30

STANDARD

Submissions Property Types

ORIG

1

Null

10

CDER Filings

CIPLA USA INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212527
            [companyName] => CIPLA USA INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE","activeIngredients":"DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE","strength":"EQ 50MG BASE; 300MG; 25MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2022","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\\\/2022\\\/212527Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)