NDA 200244

HETERO DRUGS LTD

FDA Drug Application

Application #200244

Documents

• Letter: 2010-09-17

Application Sponsors

NDA 200244

HETERO DRUGS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

150MG; 200MG; 30MG

0

LAMIVUDINE, NEVIRAPINE, AND STAVUDINE

LAMIVUDINE; NEVIRAPINE; STAVUDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2010-09-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HETERO DRUGS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200244
            [companyName] => HETERO DRUGS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE, NEVIRAPINE, AND STAVUDINE","activeIngredients":"LAMIVUDINE; NEVIRAPINE; STAVUDINE","strength":"150MG; 200MG; 30MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2010","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200244s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2010-09-10
        )

)