NDA 021044

PURDUE PHARMA LP

FDA Drug Application

Application #021044

Documents

• Label: 2014-04-16
• Other Important Information from FDA: 2005-04-15
• Letter: 2004-09-27
• Letter: 2014-04-17
• Label: 2004-09-24
• Review: 2005-11-30
• Medication Guide: 2009-11-20

Application Sponsors

NDA 021044

PURDUE PHARMA LP

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	12MG	0	PALLADONE	HYDROMORPHONE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	16MG	0	PALLADONE	HYDROMORPHONE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	24MG	0	PALLADONE	HYDROMORPHONE HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	32MG	0	PALLADONE	HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-09-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-04-16	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	13	Null	7

CDER Filings

PURDUE PHARMA LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21044
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088670.pdf"]
            [products] => [{"drugName":"PALLADONE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"12MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PALLADONE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"16MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PALLADONE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"24MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PALLADONE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"32MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/16\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021044s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021044s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PALLADONE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"12MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PALLADONE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"16MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PALLADONE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"24MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PALLADONE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"32MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-04-16
        )

)