ANDA 091579

MACLEODS PHARMS LTD

FDA Drug Application

Application #091579

Documents

• Letter: 2011-08-31

Application Sponsors

ANDA 091579

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

600MG

0

EFAVIRENZ

EFAVIRENZ

FDA Submissions

ORIG

1

TA

2011-08-29

Submissions Property Types

ORIG

1

Null

42

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91579
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EFAVIRENZ","submission":"EFAVIRENZ","actionType":"600MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)