NDA 207315

HETERO LABS LTD III

FDA Drug Application

Application #207315

Documents

• Letter: 2017-05-09

Application Sponsors

NDA 207315

HETERO LABS LTD III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

75MG;75MG

0

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2017-05-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207315
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"75MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2017","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\\\/2017\\\/207315Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-05
        )

)