ANDA 077822

MALLINCKRODT

FDA Drug Application

Application #077822

Application Sponsors

ANDA 077822

MALLINCKRODT

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	10MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE; ORAL	20MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE; ORAL	40MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE; ORAL	80MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2008-07-24

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77822
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)