Documents
Application Sponsors
| NDA 022304 | COLLEGIUM PHARM INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 50MG BASE | 1 | NUCYNTA | TAPENTADOL HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 75MG BASE | 1 | NUCYNTA | TAPENTADOL HYDROCHLORIDE |
| 003 | TABLET;ORAL | EQ 100MG BASE | 1 | NUCYNTA | TAPENTADOL HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2008-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-11-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-11-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2013-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2013-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2013-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 19 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 21 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 6 |
CDER Filings
COLLEGIUM PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22304
[companyName] => COLLEGIUM PHARM INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/022304s023lbl.pdf#page=33"]
[products] => [{"drugName":"NUCYNTA","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NUCYNTA","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;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\\\/022304s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022304s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022304s019s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-19","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022304s019s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022304s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022304s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022304s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s014s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s014s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s014s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2013","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s007s008s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s007s008s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s007s008s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s007s008s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022304s007s008s009s011s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022304s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022304s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2010","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022304s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2009","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022304s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022304s000lbl_v2.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NUCYNTA","submission":"TAPENTADOL HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NUCYNTA","submission":"TAPENTADOL HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NUCYNTA","submission":"TAPENTADOL HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-03-04
)
)