NDA 204119

HETERO DRUGS LTD

FDA Drug Application

Application #204119

Documents

• Letter: 2012-11-13

Application Sponsors

NDA 204119

HETERO DRUGS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

600MG;300MG;300MG

0

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2017-06-30

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HETERO DRUGS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204119
            [companyName] => HETERO DRUGS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG;300MG;300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/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\\\/2012\\\/204119Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-30
        )

)