ANDA 213579

CIPLA USA

FDA Drug Application

Application #213579

Documents

• Letter: 2022-02-04

Application Sponsors

ANDA 213579

CIPLA USA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

CIPLA USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213579
            [companyName] => CIPLA USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR; LAMIVUDINE","activeIngredients":"DOLUTEGRAVIR;LAMIVUDINE","strength":"50MG;00MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213579Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-28
        )

)