ANDA 040257

MALLINCKRODT

FDA Drug Application

Application #040257

Documents

• Label: 2004-06-10
• Review: 2003-07-31
• Letter: 1998-08-04

Application Sponsors

ANDA 040257

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

500MG;5MG

0

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1998-08-04

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40257
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/04\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/40257_Oxycodone%20and%20Acetaminophen_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-08-04
        )

)