ANDA 202990

PAR FORMULATIONS PRIVATE LTD

FDA Drug Application

Application #202990

Documents

• Letter: 2012-06-28

Application Sponsors

ANDA 202990

PAR FORMULATIONS PRIVATE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

600MG

0

EFAVIRENZ

EFAVIRENZ

FDA Submissions

UNKNOWN;

ORIG

1

TA

2012-06-25

Submissions Property Types

ORIG

1

Null

1

CDER Filings

PAR FORMULATIONS PRIVATE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202990
            [companyName] => PAR FORMULATIONS PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202990s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-06-25
        )

)