PURDUE PHARMA LP FDA Approval NDA 022272

NDA 022272

PURDUE PHARMA LP

FDA Drug Application

Application #022272

Documents

Letter2010-04-09
Letter2010-07-01
Letter2010-11-22
Letter2011-10-11
Letter2012-07-11
Letter2012-07-11
Letter2013-01-14
Letter2014-04-17
Letter2015-07-06
Label2010-04-06
Label2011-10-12
Label2014-04-16
Label2014-10-30
Label2015-08-13
Review2010-09-29
Other2015-11-04
Letter2013-04-16
Letter2013-04-16
Letter2014-10-30
Letter2014-08-20
Letter2015-08-13
Label2010-07-01
Label2010-11-26
Label2012-07-12
Label2012-07-13
Label2013-04-16
Label2013-01-15
Review2013-04-26
Review2015-09-29
Other Important Information from FDA2013-02-15
Other2010-08-06
Summary Review2011-02-17
Letter2016-10-04
Letter2016-12-20
Label2016-12-21
Letter2017-05-30
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-09-27
Letter2018-10-01
Letter2018-10-01
Letter2018-10-01
Label2018-10-01
Label2018-10-01
Label2019-10-08
Medication Guide2019-10-09
Letter2019-10-09
Letter2019-11-15
Medication Guide2019-11-15
Letter2021-03-05
Label2021-03-08
Medication Guide2021-03-08
Letter2021-10-29
Label2021-10-29
Medication Guide2021-10-29

Application Sponsors

NDA 022272PURDUE PHARMA LP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MG1OXYCONTINOXYCODONE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL15MG1OXYCONTINOXYCODONE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL20MG1OXYCONTINOXYCODONE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL30MG1OXYCONTINOXYCODONE HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL40MG1OXYCONTINOXYCODONE HYDROCHLORIDE
006TABLET, EXTENDED RELEASE;ORAL60MG1OXYCONTINOXYCODONE HYDROCHLORIDE
007TABLET, EXTENDED RELEASE;ORAL80MG1OXYCONTINOXYCODONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2010-04-05PRIORITY
REMS; REMSSUPPL5AP2010-06-29N/A
LABELING; LabelingSUPPL6AP2010-11-15UNKNOWN
LABELING; LabelingSUPPL9AP2011-10-05UNKNOWN
LABELING; LabelingSUPPL10AP2012-07-09STANDARD
LABELING; LabelingSUPPL11AP2012-07-09STANDARD
EFFICACY; EfficacySUPPL14AP2013-04-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2014-02-04PRIORITY
LABELING; LabelingSUPPL16AP2013-01-11STANDARD
REMS; REMSSUPPL17AP2013-04-15N/A
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2014-01-31PRIORITY
LABELING; LabelingSUPPL22AP2014-04-16901 REQUIRED
LABELING; LabelingSUPPL23AP2014-10-22STANDARD
REMS; REMSSUPPL24AP2014-08-19N/A
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2014-10-13PRIORITY
EFFICACY; EfficacySUPPL27AP2015-08-13PRIORITY
REMS; REMSSUPPL28AP2015-06-26N/A
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2015-09-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2015-11-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2016-03-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2016-03-28PRIORITY
REMS; REMSSUPPL33AP2016-04-20N/A
LABELING; LabelingSUPPL34AP2016-12-16STANDARD
REMS; REMSSUPPL36AP2016-09-30N/A
REMS; REMSSUPPL37AP2017-05-26N/A
LABELING; LabelingSUPPL39AP2018-09-26STANDARD
REMS; REMSSUPPL40AP2018-09-18N/A
LABELING; LabelingSUPPL41AP2018-09-18STANDARD
REMS; REMSSUPPL42AP2019-11-14N/A
LABELING; LabelingSUPPL43AP2019-10-07STANDARD
LABELING; LabelingSUPPL46AP2021-03-04STANDARD
LABELING; LabelingSUPPL47AP2021-10-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL5Null6
SUPPL6Null6
SUPPL9Null7
SUPPL10Null15
SUPPL11Null6
SUPPL14Null7
SUPPL15Null0
SUPPL16Null6
SUPPL17Null6
SUPPL20Null0
SUPPL22Null7
SUPPL23Null15
SUPPL24Null6
SUPPL25Null0
SUPPL27Null8
SUPPL28Null15
SUPPL29Null0
SUPPL30Null0
SUPPL31Null0
SUPPL32Null0
SUPPL33Null6
SUPPL34Null6
SUPPL36Null7
SUPPL37Null7
SUPPL39Null7
SUPPL40Null7
SUPPL41Null7
SUPPL42Null15
SUPPL43Null6
SUPPL46Null7
SUPPL47Null15

CDER Filings

PURDUE PHARMA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22272
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022272s042MG.pdf"]
            [products] => [{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYCONTIN","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022272s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2018","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022272s039lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022272s040s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-40","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022272s040s041lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022272s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2015","submission":"SUPPL-27","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022272s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022272Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022272s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2013","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022272Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022272s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022272s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022272s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-10","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022272s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022272s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2010","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022272s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2010","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022272s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022272lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OXYCONTIN","submission":"OXYCODONE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)
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