ANDA 077677

WOCKHARDT LTD

FDA Drug Application

Application #077677

Documents

• Letter: 2010-01-05

Application Sponsors

ANDA 077677

WOCKHARDT LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	325MG;50MG	0	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
002	TABLET;ORAL	650MG;100MG	0	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

FDA Submissions

ORIG

1

AP

2007-03-16

Submissions Property Types

ORIG

1

Null

0

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77677
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","strength":"325MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","strength":"650MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","actionType":"325MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE","actionType":"650MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)