NDA 204568

CIPLA

FDA Drug Application

Application #204568

Documents

• Letter: 2013-12-31

Application Sponsors

NDA 204568

CIPLA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

600MG

0

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2013-12-30

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204568
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/30\/2013","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\\\/2013\\\/204568Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-12-30
        )

)