Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| 002 | TABLET;SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | 1 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2002-10-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-10-04 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2011-12-22 | N/A |
| LABELING; Labeling | SUPPL | 8 | AP | 2011-12-22 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2013-08-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2013-10-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-12-11 | STANDARD |
| REMS; REMS | SUPPL | 16 | AP | 2015-09-22 | N/A |
| REMS; REMS | SUPPL | 17 | AP | 2016-07-07 | N/A |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-09-07 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2017-09-19 | N/A |
| LABELING; Labeling | SUPPL | 22 | AP | 2018-02-01 | STANDARD |
| REMS; REMS | SUPPL | 23 | AP | 2018-06-11 | N/A |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-10-31 | STANDARD |
| REMS; REMS | SUPPL | 25 | AP | 2018-10-26 | N/A |
| LABELING; Labeling | SUPPL | 26 | AP | 2019-10-07 | STANDARD |
| REMS; REMS | SUPPL | 27 | AP | 2020-03-02 | N/A |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-03-04 | STANDARD |
| REMS; REMS | SUPPL | 29 | AP | 2021-11-19 | N/A |
| REMS; REMS | SUPPL | 30 | AP | 2022-05-03 | N/A |
| LABELING; Labeling | SUPPL | 31 | AP | 2022-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2022-06-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 11 | Null | 14 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 31 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Orphan | 5 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 15 |
CDER Filings
INDIVIOR INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20733
[companyName] => INDIVIOR INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020733s024lbl.pdf#page=30"]
[products] => [{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SUBOXONE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/31\/2019","submission":"SUPPL-24","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020733s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2018","submission":"SUPPL-23","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022410s033,020732s019,020733s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020733s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020733s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020733s018s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020733s018s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020733s018s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020733Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2011","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020733s007s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2011","submission":"SUPPL-7","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020733s007s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20732,20733lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SUBOXONE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 8MG BASE;EQ 2MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-31
)
)