NDA 022420

STRIDES ARCOLAB LTD

FDA Drug Application

Application #022420

Documents

• Letter: 2010-03-10

Application Sponsors

NDA 022420

STRIDES ARCOLAB LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

200MG

0

EFAVIRENZ 200MG SCORED TABLETS

EFAVIRENZ

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2010-02-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

STRIDES ARCOLAB LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22420
            [companyName] => STRIDES ARCOLAB LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ 200MG SCORED TABLETS","activeIngredients":"EFAVIRENZ","strength":"200MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EFAVIRENZ 200MG SCORED TABLETS","submission":"EFAVIRENZ","actionType":"200MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)