PURDUE PHARMA LP FDA Approval NDA 021306

NDA 021306

PURDUE PHARMA LP

FDA Drug Application

Application #021306

Documents

Letter2014-04-17
Letter2014-07-01
Letter2014-08-20
Label2010-07-06
Label2011-07-06
Label2014-07-02
Label2013-07-30
Label2014-04-16
Other2010-08-05
Letter2010-07-02
Letter2011-07-07
Letter2011-07-07
Letter2012-07-11
Letter2013-04-16
Letter2014-07-01
Letter2013-07-29
Letter2015-07-06
Letter2016-04-22
Label2011-07-06
Label2012-07-12
Label2014-07-02
Review2011-09-26
Summary Review2011-09-26
Letter2016-10-04
Letter2016-12-20
Label2016-12-21
Label2017-05-31
Letter2017-08-21
Label2017-10-18
Letter2017-10-18
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Letter2018-10-01
Letter2018-10-01
Label2018-10-17
Label2018-10-17
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-08
Letter2021-03-05
Label2021-03-08
Medication Guide2021-03-08
Letter2022-06-21
Label2022-06-21
Medication Guide2022-06-21

Application Sponsors

NDA 021306PURDUE PHARMA LP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL5MCG/HR1BUTRANSBUPRENORPHINE
002FILM, EXTENDED RELEASE;TRANSDERMAL10MCG/HR1BUTRANSBUPRENORPHINE
003FILM, EXTENDED RELEASE;TRANSDERMAL20MCG/HR1BUTRANSBUPRENORPHINE
004FILM, EXTENDED RELEASE;TRANSDERMAL15MCG/HR1BUTRANSBUPRENORPHINE
005FILM, EXTENDED RELEASE;TRANSDERMAL7.5MCG/HR1BUTRANSBUPRENORPHINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-06-30STANDARD
LABELING; LabelingSUPPL3AP2011-07-01STANDARD
LABELING; LabelingSUPPL8AP2012-07-09STANDARD
REMS; REMSSUPPL12AP2013-04-15N/A
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2013-03-08STANDARD
LABELING; LabelingSUPPL15AP2014-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-07-25STANDARD
LABELING; LabelingSUPPL18AP2014-04-16901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2014-06-30STANDARD
REMS; REMSSUPPL20AP2014-08-19N/A
REMS; REMSSUPPL22AP2015-06-26N/A
REMS; REMSSUPPL23AP2016-04-20N/A
LABELING; LabelingSUPPL24AP2016-12-16STANDARD
REMS; REMSSUPPL26AP2016-09-30N/A
EFFICACY; EfficacySUPPL27AP2017-10-13STANDARD
REMS; REMSSUPPL30AP2017-05-26N/A
REMS; REMSSUPPL31AP2017-08-14N/A
REMS; REMSSUPPL32AP2018-09-18N/A
LABELING; LabelingSUPPL34AP2018-09-18STANDARD
LABELING; LabelingSUPPL35AP2019-10-07STANDARD
LABELING; LabelingSUPPL37AP2021-03-04STANDARD
LABELING; LabelingSUPPL39AP2022-06-17STANDARD

Submissions Property Types

ORIG1Null40
SUPPL3Null7
SUPPL8Null7
SUPPL12Null15
SUPPL13Null0
SUPPL15Null15
SUPPL16Null0
SUPPL18Null7
SUPPL19Null0
SUPPL20Null15
SUPPL22Null31
SUPPL23Null15
SUPPL24Null6
SUPPL26Null31
SUPPL27Null6
SUPPL30Null7
SUPPL31Null15
SUPPL32Null15
SUPPL34Null15
SUPPL35Null6
SUPPL37Null15
SUPPL39Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

PURDUE PHARMA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21306
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021306s035lbl.pdf#page=42"]
            [products] => [{"drugName":"BUTRANS","activeIngredients":"BUPRENORPHINE","strength":"5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BUTRANS","activeIngredients":"BUPRENORPHINE","strength":"10MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BUTRANS","activeIngredients":"BUPRENORPHINE","strength":"20MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"BUTRANS","activeIngredients":"BUPRENORPHINE","strength":"15MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BUTRANS","activeIngredients":"BUPRENORPHINE","strength":"7.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021306s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021306s032s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021306s032s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-32","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021306s032s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2017","submission":"SUPPL-27","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021306s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2017","submission":"SUPPL-30","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021306Orig1s030ltr.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021306s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021306s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2014","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021306s015s019lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/30\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021306s015s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021306s015s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021306s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-16","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021306s016lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/09\/2012","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021306s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021306s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021306s001s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021306s001s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021306s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BUTRANS","submission":"BUPRENORPHINE","actionType":"5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BUTRANS","submission":"BUPRENORPHINE","actionType":"10MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BUTRANS","submission":"BUPRENORPHINE","actionType":"20MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BUTRANS","submission":"BUPRENORPHINE","actionType":"15MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BUTRANS","submission":"BUPRENORPHINE","actionType":"7.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)
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