NDA 202814

CIPLA LIMITED

FDA Drug Application

Application #202814

Documents

• Letter: 2012-06-18

Application Sponsors

NDA 202814

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, FOR SUSPENSION; ORAL

30MG; 60MG

0

LAMIVUDINE; ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2012-06-15

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202814
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; ZIDOVUDINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"30MG; 60MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/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\\\/202814s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-06-15
        )

)