Documents
Application Sponsors
| NDA 203794 | COLLEGIUM PHARM INC | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | EQ 20MG BASE/ML | 1 | NUCYNTA | TAPENTADOL HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2012-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 31 |
| SUPPL | 9 | Null | 15 |
CDER Filings
COLLEGIUM PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203794
[companyName] => COLLEGIUM PHARM INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/203794s009lbl.pdf#page=35"]
[products] => [{"drugName":"NUCYNTA","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 20MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203794s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203794s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203794s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203794s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203794s002s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203794s002s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203794s002s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203794s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/15\/2012","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\\\/2012\\\/203794s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203794Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203794_nucynta_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203794Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203794s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203794Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/07\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203794s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203794Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203794Orig1s005s006ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf#page=34\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203794Orig1s005s006ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203794s005s006lbl.pdf#page=34\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203794s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203794Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203794s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203794Orig1s002,s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203794s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203794Orig1s002,s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/16\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-03-04
)
)