ANDA 090786

WOCKHARDT LTD

FDA Drug Application

Application #090786

Documents

• Letter: 2012-12-18

Application Sponsors

ANDA 090786

WOCKHARDT LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

12.5MG;200MG;50MG

0

CARBIDOPA, LEVODOPA AND ENTACAPONE

CARBIDOPA; ENTACAPONE; LEVODOPA

FDA Submissions

ORIG

1

AP

2012-11-20

Submissions Property Types

ORIG

1

Null

7

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90786
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"12.5MG;200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"12.5MG;200MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)