NDA 022356

HETERO DRUGS LTD

FDA Drug Application

Application #022356

Documents

• Letter: 2010-03-10

Application Sponsors

NDA 022356

HETERO DRUGS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

150MG; 300MG; 200MG

0

LAMIVUDINE, ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG

LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2009-05-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HETERO DRUGS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22356
            [companyName] => HETERO DRUGS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE, ZIDOVUDINE TABS 150MG\/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG","activeIngredients":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","strength":"150MG; 300MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE, ZIDOVUDINE TABS 150MG\/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG","submission":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","actionType":"150MG; 300MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)