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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207932
Company: BDSI

Medication Guide

REMS

Products on NDA 207932

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207932

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-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-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

Labels for NDA 207932

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-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-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

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