Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020732
Company: INDIVIOR
Company: INDIVIOR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL | Discontinued | None | Yes | No |
| SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/08/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020732Orig1s027, 028ltr.pdf | |
| 06/17/2022 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020732Orig1s027, 028ltr.pdf | |
| 05/03/2022 | SUPPL-26 | 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-25 | 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-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020732Orig1s024ltr.pdf | |
| 03/02/2020 | SUPPL-23 | 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-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020732Orig1s022ltr.pdf | |
| 10/26/2018 | SUPPL-21 | 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-20 | REMS-Modified, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s034, 020732Orig1s020, 020733Orig1s024ltr.pdf | |
| 06/11/2018 | SUPPL-19 | 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-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s018ltr.pdf | |
| 09/19/2017 | SUPPL-17 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf |
| 09/07/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020732s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s016ltr.pdf | |
| 12/16/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf | |
| 12/16/2016 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf | |
| 07/07/2016 | SUPPL-13 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf |
| 09/22/2015 | SUPPL-12 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf |
| 12/11/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020732Orig1s010ltr.pdf | |
| 08/08/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2011 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf | |
| 12/22/2011 | SUPPL-6 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf | |
| 10/04/2006 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/17/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf | |
| 06/17/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf | |
| 03/04/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf | |
| 10/31/2019 | SUPPL-20 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf | |
| 10/31/2019 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf | |
| 10/07/2019 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf | |
| 10/07/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf | |
| 06/11/2018 | SUPPL-19 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf | |
| 02/01/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf | |
| 09/07/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020732s016lbl.pdf | |
| 12/16/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf | |
| 12/16/2016 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf | |
| 12/16/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf | |
| 12/11/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf | |
| 12/22/2011 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf | |
| 12/22/2011 | SUPPL-6 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf | |
| 10/08/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf |