NDA 021971

CIPLA LIMITED

FDA Drug Application

Application #021971

Documents

• Letter: 2007-02-12

Application Sponsors

NDA 021971

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

150MG; 300MG; 200MG

0

LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE

LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2007-01-31

PRIORITY

Submissions Property Types

ORIG

1

Null

10

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21971
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","strength":"150MG; 300MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","submission":"LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE","actionType":"150MG; 300MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)