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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205637
Company: BDSI

Medication Guide

REMS

Summary Review

Products on NDA 205637

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2.1MG BASE;EQ 0.3MG BASE	FILM;BUCCAL	Discontinued	None	Yes	No
BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4.2MG BASE;EQ 0.7MG BASE	FILM;BUCCAL	Discontinued	None	Yes	No
BUNAVAIL	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 6.3MG BASE;EQ 1MG BASE	FILM;BUCCAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205637

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205637Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2022	SUPPL-25	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205637Orig1s025ltr.pdf
06/17/2022	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205637Orig1s023, s024ltr.pdf
06/17/2022	SUPPL-23	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205637Orig1s023, s024ltr.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/2022/205637Orig1s022ltr.pdf
03/04/2021	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205637Orig1s021ltr.pdf
10/07/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205637Orig1s020ltr.pdf
10/31/2018	SUPPL-19	REMS - PROPOSAL - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s019ltr.pdf
02/01/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s016ltr.pdf
05/23/2017	SUPPL-14	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s014ltr.pdf
04/27/2017	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf
12/16/2016	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s011ltr.pdf
07/07/2016	SUPPL-9	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf
04/27/2017	SUPPL-7	Efficacy-New Dosing Regimen, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf
10/14/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/12/2015	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf
04/24/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/25/2018	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 205637

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2022	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf
06/17/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf
03/04/2021	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf
10/07/2019	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
10/07/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
02/01/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf
04/27/2017	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017	SUPPL-7	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
12/16/2016	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
06/06/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf

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