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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/30/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022410s052lbl.pdf | |
| 03/20/2024 | SUPPL-50 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022410Orig1s050ltr.pdf |
| 03/13/2023 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022410s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022410Orig1s049ltr.pdf | |
| 12/16/2022 | SUPPL-48 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022410Orig1s048ltr.pdf |
| 06/17/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022410Orig1s046, s047ltr.pdf | |
| 06/17/2022 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022410Orig1s046, s047ltr.pdf | |
| 05/03/2022 | SUPPL-45 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020732Orig1s026, 020733Orig1s030, 022410Orig1s045ltr.pdf |
| 11/19/2021 | SUPPL-44 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020732Orig1s025; 020733Orig1s029; 022410Orig1s044ltr.pdf |
| 03/04/2021 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022410s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022410Orig1s042ltr.pdf | |
| 03/02/2020 | SUPPL-39 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020732Orig1s023, 020733Orig1s027, 022410Orig1s039ltr.pdf |
| 10/07/2019 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s038ltr.pdf | |
| 10/26/2018 | SUPPL-35 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022410Orig1s035,020733Orig1s025,020732Orig1s021Ltr.pdf |
| 10/31/2019 | SUPPL-34 | Labeling-Medication Guide, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s034, 020732Orig1s020, 020733Orig1s024ltr.pdf | |
| 06/11/2018 | SUPPL-33 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s019,020733Orig1s023,022410Orig1s033ltr.pdf | |
| 02/01/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022410Orig1s031ltr.pdf | |
| 09/19/2017 | SUPPL-30 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf |
| 09/19/2017 | SUPPL-29 | REMS-Assessment |
Label is not available on this site. |
||
| 01/12/2017 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf | |
| 12/16/2016 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf | |
| 07/07/2016 | SUPPL-25 | REMS-Assessment |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf |
| 04/15/2016 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/2017 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022410Orig1s023ltr.pdf | |
| 09/22/2015 | SUPPL-22 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf | |
| 06/23/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-20 | Efficacy-New Route Of Administration |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf | |
| 08/12/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/2014 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf | |
| 04/28/2014 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf | |
| 06/05/2014 | SUPPL-16 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s016.pdf |
| 11/22/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022410Orig1s015ltr.pdf | |
| 03/12/2014 | SUPPL-14 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s014.pdf |
| 08/08/2013 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022410Orig1s011.pdf |
| 08/10/2012 | SUPPL-7 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s007.pdf | |
| 08/10/2012 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s006.pdf | |
| 04/28/2014 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
SUBOXONE
FILM;BUCCAL, SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205299 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 211785 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 8MG BASE;EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 212756 | AVEVA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205299 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 4MG BASE;EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205806 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 211785 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 212756 | AVEVA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205806 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |