ANDA 078941

WOCKHARDT LTD

FDA Drug Application

Application #078941

Application Sponsors

ANDA 078941

WOCKHARDT LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

ENTACAPONE

ENTACAPONE

FDA Submissions

ORIG

1

AP

2012-08-16

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78941
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTACAPONE","activeIngredients":"ENTACAPONE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENTACAPONE","submission":"ENTACAPONE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)