NDA 021745

PURDUE PHARMA

FDA Drug Application

Application #021745

Documents

• Review: 2009-07-06
• Letter: 2009-01-02
• Label: 2009-01-02
• Summary Review: 2009-07-06

Application Sponsors

NDA 021745

PURDUE PHARMA

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	RYZOLT	TRAMADOL HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	RYZOLT	TRAMADOL HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	RYZOLT	TRAMADOL HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2008-12-30

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

PURDUE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21745
            [companyName] => PURDUE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYZOLT","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RYZOLT","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RYZOLT","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/30\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021745s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RYZOLT","submission":"TRAMADOL HYDROCHLORIDE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RYZOLT","submission":"TRAMADOL HYDROCHLORIDE","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RYZOLT","submission":"TRAMADOL HYDROCHLORIDE","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-12-30
        )

)