NDA 200623

CIPLA LIMITED

FDA Drug Application

Application #200623

Documents

• Letter: 2011-03-10

Application Sponsors

NDA 200623

CIPLA LIMITED

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 4; Type 4 - New Combination

ORIG

1

TA

2011-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200623
            [companyName] => CIPLA LIMITED
            [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":"03\/04\/2011","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\\\/2011\\\/200623s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-03-04
        )

)