NDA 205493

MICRO LABS LTD

FDA Drug Application

Application #205493

Documents

• Letter: 2018-01-30

Application Sponsors

NDA 205493

MICRO LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2018-01-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MICRO LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205493
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2018","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\\\/2018\\\/205493Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-25
        )

)