NDA 205355

HETERO LABS LTD III

FDA Drug Application

Application #205355

Documents

• Letter: 2014-03-19

Application Sponsors

NDA 205355

HETERO LABS LTD III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

300MG; 300MG; 200MG

0

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2014-03-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205355
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE","activeIngredients":"LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE","strength":"300MG; 300MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/14\/2014","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\\\/2014\\\/205355Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-03-14
        )

)