NDA 205861

MACLEODS PHARMS LTD

FDA Drug Application

Application #205861

Documents

• Letter: 2014-08-15

Application Sponsors

NDA 205861

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

600MG;300MG;300MG

0

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2014-08-14

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205861
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG;300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2014","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\\\/2014\\\/205861Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-14
        )

)