ANDA 078786

WOCKHARDT LTD

FDA Drug Application

Application #078786

Application Sponsors

ANDA 078786

WOCKHARDT LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	3.125MG	0	CARVEDILOL	CARVEDILOL
002	TABLET;ORAL	6.25MG	0	CARVEDILOL	CARVEDILOL
003	TABLET;ORAL	12.5MG	0	CARVEDILOL	CARVEDILOL
004	TABLET;ORAL	25MG	0	CARVEDILOL	CARVEDILOL

FDA Submissions

ORIG

1

AP

2009-12-22

Submissions Property Types

ORIG

1

Null

7

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78786
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"3.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARVEDILOL","activeIngredients":"CARVEDILOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"3.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL","submission":"CARVEDILOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)