NDA 206451

CIPLA

FDA Drug Application

Application #206451

Documents

• Letter: 2017-10-31

Application Sponsors

NDA 206451

CIPLA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2017-10-27

PRIORITY

Submissions Property Types

ORIG

1

Null

1

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206451
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR AND RITONAVIR","activeIngredients":"ATAZANAVIR; RITONAVIR","strength":"300MG\/100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206451Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-27
        )

)