Documents
Application Sponsors
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 002 | TABLET;SUBLINGUAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE |
| 003 | TABLET;SUBLINGUAL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-10-04 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2011-12-22 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-12-22 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-12-11 | STANDARD |
| REMS; REMS | SUPPL | 12 | AP | 2015-09-22 | N/A |
| REMS; REMS | SUPPL | 13 | AP | 2016-07-07 | N/A |
| LABELING; Labeling | SUPPL | 14 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-09-07 | STANDARD |
| REMS; REMS | SUPPL | 17 | AP | 2017-09-19 | N/A |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-02-01 | STANDARD |
| REMS; REMS | SUPPL | 19 | AP | 2018-06-11 | N/A |
| LABELING; Labeling | SUPPL | 20 | AP | 2019-10-31 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2018-10-26 | N/A |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-10-07 | STANDARD |
| REMS; REMS | SUPPL | 23 | AP | 2020-03-02 | N/A |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-03-04 | STANDARD |
| REMS; REMS | SUPPL | 25 | AP | 2021-11-19 | N/A |
| REMS; REMS | SUPPL | 26 | AP | 2022-05-03 | N/A |
| LABELING; Labeling | SUPPL | 27 | AP | 2022-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2022-06-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Orphan | 5 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Orphan | 5 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 15 |
CDER Filings
INDIVIOR INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20732
[companyName] => INDIVIOR INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020732s020lbl.pdf#page=27"]
[products] => [{"drugName":"SUBUTEX","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 2MG 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":"SUBUTEX","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 8MG 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"}]
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[originalApprovals] => [{"actionDate":"SUBUTEX","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 2MG 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":"SUBUTEX","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-31
)
)