PURDUE PHARMA LP FDA Approval NDA 019516

NDA 019516

PURDUE PHARMA LP

FDA Drug Application

Application #019516

Documents

Letter2004-06-09
Letter2007-05-29
Letter2010-05-14
Letter2012-07-11
Letter2014-10-30
Letter2014-08-20
Letter2016-04-22
Letter2003-08-14
Letter2012-07-11
Letter2013-04-16
Letter2014-04-17
Letter2015-06-29
Other2012-07-11
Label2010-05-17
Label2012-07-12
Label2012-07-13
Label2014-04-16
Label2014-10-30
Letter2016-10-04
Letter2016-12-20
Label2016-12-21
Letter2017-05-31
Letter2018-09-28
Letter2018-09-28
Label2018-10-05
Label2018-10-05
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-08
Label2021-03-05
Medication Guide2021-03-05
Letter2021-03-05

Application Sponsors

NDA 019516PURDUE PHARMA LP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET, EXTENDED RELEASE;ORAL30MG1MS CONTINMORPHINE SULFATE
002TABLET, EXTENDED RELEASE;ORAL60MG1MS CONTINMORPHINE SULFATE
003TABLET, EXTENDED RELEASE;ORAL15MG1MS CONTINMORPHINE SULFATE
004TABLET, EXTENDED RELEASE;ORAL100MG1MS CONTINMORPHINE SULFATE
005TABLET, EXTENDED RELEASE;ORAL200MG1MS CONTINMORPHINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1987-05-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1989-09-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1990-01-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-11-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-05-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1990-04-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-04-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-05-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-05-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-05-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-05-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-05-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-06-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-05-02PRIORITY
LABELING; LabelingSUPPL15AP2001-02-12STANDARD
LABELING; LabelingSUPPL16AP2001-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2003-02-21PRIORITY
LABELING; LabelingSUPPL21AP2003-08-06STANDARD
LABELING; LabelingSUPPL30AP2007-05-11STANDARD
LABELING; LabelingSUPPL34AP2010-05-11UNKNOWN
REMS; REMSSUPPL36AP2012-07-09N/A
LABELING; LabelingSUPPL37AP2012-07-09STANDARD
REMS; REMSSUPPL38AP2013-04-15N/A
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2014-06-02PRIORITY
LABELING; LabelingSUPPL42AP2014-04-16901 REQUIRED
LABELING; LabelingSUPPL43AP2014-10-22STANDARD
REMS; REMSSUPPL44AP2014-08-19N/A
REMS; REMSSUPPL46AP2015-06-26N/A
REMS; REMSSUPPL47AP2016-04-20N/A
LABELING; LabelingSUPPL49AP2016-12-16STANDARD
REMS; REMSSUPPL50AP2016-09-30N/A
REMS; REMSSUPPL52AP2017-05-26N/A
REMS; REMSSUPPL53AP2018-09-18N/A
LABELING; LabelingSUPPL54AP2018-09-18STANDARD
LABELING; LabelingSUPPL55AP2019-10-07STANDARD
LABELING; LabelingSUPPL57AP2021-03-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL19Null0
SUPPL34Null7
SUPPL36Null7
SUPPL37Null7
SUPPL38Null15
SUPPL40Null0
SUPPL42Null7
SUPPL43Null15
SUPPL44Null6
SUPPL46Null15
SUPPL47Null6
SUPPL49Null6
SUPPL50Null6
SUPPL52Null15
SUPPL53Null6
SUPPL54Null6
SUPPL55Null7
SUPPL57Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

PURDUE PHARMA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19516
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/019516s055lbl.pdf#page=27"]
            [products] => [{"drugName":"MS CONTIN","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MS CONTIN","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MS CONTIN","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MS CONTIN","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MS CONTIN","activeIngredients":"MORPHINE SULFATE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-55","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019516s055lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019516s055lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019516s053s054lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019516s053s054lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-53","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019516s053s054lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019516s049lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019516s049lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019516Orig1s043lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-42","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019516s042lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019516s042lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019516s037lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-36","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019516s036lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2010","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019516s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MS CONTIN","submission":"MORPHINE SULFATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MS CONTIN","submission":"MORPHINE SULFATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MS CONTIN","submission":"MORPHINE SULFATE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MS CONTIN","submission":"MORPHINE SULFATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MS CONTIN","submission":"MORPHINE SULFATE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)
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