NDA 203283

MACLEODS PHARMS LTD

FDA Drug Application

Application #203283

Documents

• Letter: 2012-11-09

Application Sponsors

NDA 203283

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

300MG; 300MG

0

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2012-11-08

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203283
            [companyName] => MACLEODS PHARMS 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":"11\/08\/2012","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\\\/2012\\\/203283Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-11-08
        )

)