Application 020733
- Type
- NDA
- Sponsor
- INDIVIOR INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | TABLET;SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71391 | SUPPL | 2022-06-21 |
| 71390 | SUPPL | 2022-06-21 |
| 71389 | SUPPL | 2022-06-21 |
| 71367 | SUPPL | 2022-06-21 |
| 71366 | SUPPL | 2022-06-21 |
| 70984 | SUPPL | 2022-05-04 |
| 69379 | SUPPL | 2021-11-23 |
| 66621 | SUPPL | 2021-03-08 |
| 66620 | SUPPL | 2021-03-08 |
| 66504 | SUPPL | 2021-03-05 |
| 62027 | SUPPL | 2020-03-04 |
| 61011 | SUPPL | 2019-11-21 |
| 61008 | SUPPL | 2019-11-21 |
| 60771 | SUPPL | 2019-11-01 |
| 60764 | SUPPL | 2019-10-31 |
| 60424 | SUPPL | 2019-10-09 |
| 56142 | SUPPL | 2018-10-29 |
| 54611 | SUPPL | 2018-06-19 |
| 54594 | SUPPL | 2018-06-14 |
| 52287 | SUPPL | 2018-02-02 |
| 52247 | SUPPL | 2018-02-01 |
| 50047 | APPL | 2017-10-12 |
| 49840 | SUPPL | 2017-09-22 |
| 49808 | SUPPL | 2017-09-20 |
| 49695 | SUPPL | 2017-09-08 |
| 46367 | SUPPL | 2016-12-21 |
| 46366 | SUPPL | 2016-12-21 |
| 46265 | SUPPL | 2016-12-20 |
| 46264 | SUPPL | 2016-12-20 |
| 25658 | SUPPL | 2016-07-12 |
| 3228 | SUPPL | 2015-09-24 |
| 13311 | SUPPL | 2014-12-18 |
| 3227 | SUPPL | 2014-12-12 |
| 25657 | SUPPL | 2012-01-03 |
| 25656 | SUPPL | 2012-01-03 |
| 35248 | SUPPL | 2011-12-23 |
| 13310 | SUPPL | 2011-12-23 |
| 3226 | SUPPL | 2006-10-13 |
| 23596 | ORIG | 2006-10-11 |
| 41625 | ORIG | 2004-11-22 |
| 13309 | ORIG | 2002-10-08 |
| 3225 | ORIG | 2002-10-08 |