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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207932
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
06/17/2022 SUPPL-20 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
06/17/2022 SUPPL-19 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
03/04/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert 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-Medication Guide, Labeling-Package Insert 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-Medication Guide, Labeling-Package Insert 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-Package Insert, Labeling-Medication Guide 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
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-20 Labeling-Package Insert 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
06/17/2022 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf
03/04/2021 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf
03/04/2021 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf
10/07/2019 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf
10/07/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.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-9 Labeling-Package Insert 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf
12/16/2016 SUPPL-2 Labeling-Medication Guide 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
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