Documents
Application Sponsors
| NDA 208090 | COLLEGIUM PHARM INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 9MG | 1 | XTAMPZA ER | OXYCODONE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 13.5MG | 1 | XTAMPZA ER | OXYCODONE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 18MG | 1 | XTAMPZA ER | OXYCODONE |
| 004 | CAPSULE, EXTENDED RELEASE;ORAL | 27MG | 1 | XTAMPZA ER | OXYCODONE |
| 005 | CAPSULE, EXTENDED RELEASE;ORAL | 36MG | 1 | XTAMPZA ER | OXYCODONE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2016-04-26 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2016-09-30 | N/A |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2017-11-06 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2017-05-26 | N/A |
| REMS; REMS | SUPPL | 8 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 15 | Null | 6 |
CDER Filings
COLLEGIUM PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208090
[companyName] => COLLEGIUM PHARM INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/208090s015lbl.pdf#page=39"]
[products] => [{"drugName":"XTAMPZA ER","activeIngredients":"OXYCODONE","strength":"9MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XTAMPZA ER","activeIngredients":"OXYCODONE","strength":"13.5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XTAMPZA ER","activeIngredients":"OXYCODONE","strength":"18MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XTAMPZA ER","activeIngredients":"OXYCODONE","strength":"27MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XTAMPZA ER","activeIngredients":"OXYCODONE","strength":"36MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208090s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208090s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208090s008s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208090s008s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208090s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208090s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208090s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208090s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208090Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208090Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208090s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208090Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"10\/07\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208090s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208090Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208090s008s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208090Orig1s008s010ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-9","supplementCategories":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208090Orig1s009Ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208090s008s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208090Orig1s008s010ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208090Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/06\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208090s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208090Orig1s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208090Orig1s004.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208090s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208090Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2016","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208090Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-03-04
)
)