ANDA 090833

WOCKHARDT LTD

FDA Drug Application

Application #090833

Documents

• Letter: 2012-12-18

Application Sponsors

ANDA 090833

WOCKHARDT LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	18.75MG;200MG;75MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
002	TABLET;ORAL	25MG;200MG;100MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
003	TABLET;ORAL	31.25MG;200MG;125MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
004	TABLET;ORAL	37.5MG;200MG;150MG	0	CARBIDOPA, LEVODOPA AND ENTACAPONE	CARBIDOPA; ENTACAPONE; LEVODOPA
005	TABLET;ORAL	50MG;200MG;200MG	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] => 90833
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"18.75MG;200MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"25MG;200MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"31.25MG;200MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"37.5MG;200MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA, LEVODOPA AND ENTACAPONE","activeIngredients":"CARBIDOPA; ENTACAPONE; LEVODOPA","strength":"50MG;200MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"18.75MG;200MG;75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"25MG;200MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"31.25MG;200MG;125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"37.5MG;200MG;150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA, LEVODOPA AND ENTACAPONE","submission":"CARBIDOPA; ENTACAPONE; LEVODOPA","actionType":"50MG;200MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)