Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204242
Company: OREXO US INC
Company: OREXO US INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 1.4MG BASE;EQ 0.36MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | No |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 5.7MG BASE;EQ 1.4MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | No |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8.6MG BASE;EQ 2.1MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | No |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 11.4MG BASE;EQ 2.9MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | Yes |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | No |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET;SUBLINGUAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/03/2013 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204242Orig1s027ltr.pdf | |
| 03/20/2024 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204242Orig1s026ltr.pdf |
| 03/23/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204242Orig1s025ltr.pdf | |
| 12/16/2022 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s024ltr.pdf |
| 06/17/2022 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s021, s023ltr.pdf | |
| 05/03/2022 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s022ltr.pdf |
| 06/17/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s021, s023ltr.pdf | |
| 03/04/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204242s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204242Orig1s019ltr.pdf | |
| 10/07/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204242s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204242Orig1s017ltr.pdf | |
| 10/31/2018 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s015ltr.pdf |
| 02/01/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s014ltr.pdf | |
| 05/23/2017 | SUPPL-12 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s012ltr.pdf |
| 09/08/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s011ltr.pdf | |
| 12/16/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s009ltr.pdf | |
| 07/07/2016 | SUPPL-8 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf |
| 10/04/2016 | SUPPL-7 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s007ltr.pdf | |
| 06/04/2015 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf | |
| 02/12/2015 | SUPPL-5 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf |
| 08/10/2015 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf | |
| 12/11/2014 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf | |
| 09/04/2013 | SUPPL-2 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf |
| 01/14/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s027lbl.pdf | |
| 03/23/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s025lbl.pdf | |
| 06/17/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf | |
| 06/17/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf | |
| 03/04/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204242s019lbl.pdf | |
| 10/07/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204242s017lbl.pdf | |
| 10/07/2019 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204242s017lbl.pdf | |
| 02/01/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf | |
| 09/08/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf | |
| 12/16/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf | |
| 12/16/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf | |
| 10/04/2016 | SUPPL-7 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf | |
| 08/10/2015 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf | |
| 06/04/2015 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf |
| 12/11/2014 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf |
| 07/03/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf |