NDA 021969

CIPLA LIMITED

FDA Drug Application

Application #021969

Documents

• Letter: 2006-12-04

Application Sponsors

NDA 021969

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET; ORAL	150MG; 30MG; 200MG	0	LAMIVUDINE; STAVUDINE; NEVIRAPINE	LAMIVUDINE; STAVUDINE; NEVIRAPINE
002	TABLET; ORAL	150MG; 40MG; 200MG	0	LAMIVUDINE; STAVUDINE; NEVIRAPINE	LAMIVUDINE; STAVUDINE; NEVIRAPINE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2006-11-17

PRIORITY

Submissions Property Types

ORIG

1

Null

0

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21969
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","activeIngredients":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","strength":"150MG; 30MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","activeIngredients":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","strength":"150MG; 40MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","submission":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","actionType":"150MG; 30MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","submission":"LAMIVUDINE; STAVUDINE; NEVIRAPINE","actionType":"150MG; 40MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)