COLLEGIUM PHARM INC FDA Approval NDA 200533

NDA 200533

COLLEGIUM PHARM INC

FDA Drug Application

Application #200533

Documents

Letter2016-04-22
Label2011-08-26
Label2012-07-12
Other2011-08-30
Letter2011-08-29
Letter2012-08-29
Letter2012-07-11
Letter2013-04-18
Letter2014-04-17
Letter2014-08-20
Letter2015-07-07
Label2012-08-29
Label2014-04-16
Review2012-04-12
Letter2016-10-03
Label2016-12-20
Letter2016-12-21
Letter2017-05-31
Label2018-09-24
Label2018-09-24
Letter2018-10-01
Letter2018-10-01
Letter2019-10-08
Label2019-10-08
Medication Guide2019-10-08
Letter2021-03-08
Label2021-03-08
Medication Guide2021-03-08

Application Sponsors

NDA 200533COLLEGIUM PHARM INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 50MG BASE1NUCYNTA ERTAPENTADOL HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 100MG BASE1NUCYNTA ERTAPENTADOL HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 150MG BASE1NUCYNTA ERTAPENTADOL HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORALEQ 200MG BASE1NUCYNTA ERTAPENTADOL HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORALEQ 250MG BASE1NUCYNTA ERTAPENTADOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2011-08-25STANDARD
REMS; REMSSUPPL2AP2012-07-09N/A
REMS; REMSSUPPL4AP2013-04-15N/A
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2014-01-16STANDARD
LABELING; LabelingSUPPL10AP2014-04-16901 REQUIRED
REMS; REMSSUPPL11AP2014-08-19N/A
REMS; REMSSUPPL12AP2015-06-26N/A
REMS; REMSSUPPL13AP2016-04-20N/A
LABELING; LabelingSUPPL14AP2016-12-16STANDARD
REMS; REMSSUPPL15AP2016-09-30N/A
REMS; REMSSUPPL16AP2017-05-26N/A
REMS; REMSSUPPL18AP2018-09-18N/A
LABELING; LabelingSUPPL19AP2018-09-18STANDARD
LABELING; LabelingSUPPL20AP2019-10-07STANDARD
LABELING; LabelingSUPPL23AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null12
SUPPL2Null6
SUPPL4Null6
SUPPL7Null0
SUPPL10Null7
SUPPL11Null7
SUPPL12Null7
SUPPL13Null15
SUPPL14Null6
SUPPL15Null6
SUPPL16Null6
SUPPL18Null7
SUPPL19Null7
SUPPL20Null7
SUPPL23Null6

CDER Filings

COLLEGIUM PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200533
            [companyName] => COLLEGIUM PHARM INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/200533s023lbl.pdf#page=37"]
            [products] => [{"drugName":"NUCYNTA ER","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA ER","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA ER","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA ER","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA ER","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/200533s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200533s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200533s018s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-18","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200533s018s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200533s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200533s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200533s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200533s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200533s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200533s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200533s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200533s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/25\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200533s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200533s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200533Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/200533s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/200533Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"10\/07\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200533s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200533Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200533s018s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200533Orig1s018s019ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-18","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200533s018s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200533Orig1s018s019ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-16","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200533Orig1s016ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-15","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200533Orig1s015ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200533s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200533Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2016","submission":"SUPPL-13","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200533Orig1s013ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-12","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200533Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-11","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200533Orig1s011ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/16\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200533s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200533Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"01\/16\/2014","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/15\/2013","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200533Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2012","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200533s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200533Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200533s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200533Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-03-04
        )

)
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