Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022410
Company: INDIVIOR
Company: INDIVIOR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | No |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022410s057lbl.pdf | |
| 12/22/2025 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022410s057lbl.pdf | |
| 05/19/2025 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022410s056lbl.pdf | |
| 12/15/2023 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022410s052lbl.pdf | |
| 03/13/2023 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022410s049lbl.pdf | |
| 06/17/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf | |
| 06/17/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf | |
| 03/04/2021 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022410s042lbl.pdf | |
| 10/31/2019 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf | |
| 10/31/2019 | SUPPL-34 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf | |
| 10/07/2019 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf | |
| 10/07/2019 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf | |
| 06/11/2018 | SUPPL-33 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf | |
| 02/01/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s031lbl.pdf | |
| 02/13/2017 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf | |
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf | |
| 12/16/2016 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf | |
| 12/16/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf | |
| 09/22/2015 | SUPPL-22 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf | |
| 09/22/2015 | SUPPL-20 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf | |
| 04/28/2014 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf | |
| 04/28/2014 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf | |
| 04/28/2014 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf | |
| 11/22/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf | |
| 08/10/2012 | SUPPL-7 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf |
| 08/10/2012 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf |
| 08/30/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf |