NDA 022346

PHARMACARE LTD

FDA Drug Application

Application #022346

Documents

• Letter: 2009-03-05

Application Sponsors

NDA 022346

PHARMACARE LTD

Marketing Status

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

Application Products

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

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

TA

2009-02-27

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

PHARMACARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22346
            [companyName] => PHARMACARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","activeIngredients":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","strength":"30MG; 150MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","activeIngredients":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","strength":"40MG; 150MG; 200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","submission":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","actionType":"30MG; 150MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","submission":"STAVUDINE; LAMIVUDINE; NEVIRAPINE","actionType":"40MG; 150MG; 200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)