NDA 201151

CIPLA LIMITED

FDA Drug Application

Application #201151

Documents

• Letter: 2011-09-26

Application Sponsors

NDA 201151

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

30MG; 60MG

0

LAMIVUDINE; ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2011-09-22

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201151
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; ZIDOVUDINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"30MG; 60MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2011","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\\\/2011\\\/201151s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-09-22
        )

)