ANDA 078886

HETERO LABS LTD III

FDA Drug Application

Application #078886

Documents

• Letter: 2008-03-04

Application Sponsors

ANDA 078886

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

EFAVIRENZ

EFAVIRENZ

FDA Submissions

ORIG

1

AP

2018-04-27

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78886
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EFAVIRENZ","submission":"EFAVIRENZ","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)