Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207932
Company: BDSI
Company: BDSI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription | None | Yes | No |
BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
10/23/2015 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207932s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207932Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207932Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207932s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207932Orig1s023ltr.pdf | |
06/17/2022 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207932Orig1s019, s020ltr.pdf | |
06/17/2022 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207932Orig1s019, s020ltr.pdf | |
03/04/2021 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207932Orig1s015ltr.pdf | |
10/07/2019 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207932Orig1s012ltr.pdf | |
10/16/2019 | SUPPL-10 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207932Orig1s010ltr.pdf |
09/18/2018 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
09/18/2018 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207932Orig1s008s009ltr.pdf | |
05/26/2017 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207932Orig1s006ltr.pdf |
09/30/2016 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s003ltr.pdf |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s002ltr.pdf | |
04/20/2016 | SUPPL-1 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207932Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207932s023lbl.pdf | |
12/15/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207932s023lbl.pdf | |
06/17/2022 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf | |
06/17/2022 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf | |
06/17/2022 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf | |
06/17/2022 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf | |
03/04/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf | |
03/04/2021 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf | |
10/07/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf | |
10/07/2019 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf | |
09/18/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
09/18/2018 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
09/18/2018 | SUPPL-8 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207932s008s009lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf | |
10/23/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207932s000lbl.pdf |