NDA 022459

HETERO DRUGS LTD

FDA Drug Application

Application #022459

Documents

• Letter: 2010-03-22

Application Sponsors

NDA 022459

HETERO DRUGS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

300MG/300MG

0

LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS

LAMIVUDINE; TENOFOVIR

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2009-11-05

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HETERO DRUGS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22459
            [companyName] => HETERO DRUGS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE\/TENOFOVIR DISOPROXIL FUMARATE FDC TABS","activeIngredients":"LAMIVUDINE; TENOFOVIR","strength":"300MG\/300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE\/TENOFOVIR DISOPROXIL FUMARATE FDC TABS","submission":"LAMIVUDINE; TENOFOVIR","actionType":"300MG\/300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)