Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020733
Company: INDIVIOR

• Medication Guide

• Other Important Information from FDA

Products on NDA 20733

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;SUBLINGUAL	Discontinued	None	Yes	No

Labels for NDA 020733

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2022	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020733s031s032lbl.pdf
06/17/2022	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020733s031s032lbl.pdf
03/04/2021	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020733s028lbl.pdf
10/31/2019	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024lbl.pdf
10/31/2019	SUPPL-24	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024lbl.pdf
10/07/2019	SUPPL-26	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s026lbl.pdf
10/07/2019	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s026lbl.pdf
06/11/2018	SUPPL-23	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf
02/01/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020733s022lbl.pdf
09/07/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020733s020lbl.pdf
12/16/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020733s018s019lbl.pdf
12/16/2016	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020733s018s019lbl.pdf
12/16/2016	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020733s018s019lbl.pdf
12/11/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020733Orig1s014lbl.pdf
12/22/2011	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf
12/22/2011	SUPPL-7	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf
10/08/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf