NDA 206040

MYLAN LABS LTD

FDA Drug Application

Application #206040

Documents

• Letter: 2014-09-08

Application Sponsors

NDA 206040

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

150MG;300MG;600MG

0

LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ

LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2014-09-04

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206040
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ","activeIngredients":"LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ","strength":"150MG;300MG;600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/04\/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\\\/206040Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-04
        )

)