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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209819
Company: INDIVIOR

Medication Guide

REMS

Summary Review

Products on NDA 209819

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUBLOCADE	BUPRENORPHINE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
SUBLOCADE	BUPRENORPHINE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209819

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2017	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209819Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209819Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/209819Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-37	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209819s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s037ltr.pdf
04/11/2025	SUPPL-34	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s034ltr.pdf
02/21/2025	SUPPL-31	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209819Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s031ltr.pdf
04/19/2024	SUPPL-29	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209819Orig1s029ltr.pdf
12/15/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s028ltr.pdf
09/12/2023	SUPPL-26	Manufacturing (CMC)-Expiration Date	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s026ltr.pdf
07/03/2023	SUPPL-24	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s024ltr.pdf
03/13/2023	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s022ltr.pdf
01/06/2023	SUPPL-21	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s021ltr.pdf
06/17/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s020ltr.pdf
09/22/2021	SUPPL-19	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s019ltr.pdf
06/17/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s018ltr.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf
06/15/2020	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s016ltr.pdf
05/11/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s015ltr.pdf
02/04/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s012ltr.pdf
08/23/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s010ltr.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209819s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209819Orig1s009ltr.pdf
03/05/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209819Orig1s001ltr.pdf

Labels for NDA 209819

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-37	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209819s037lbl.pdf
12/22/2025	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209819s037lbl.pdf
02/21/2025	SUPPL-31	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209819Orig1s031lbl.pdf
12/15/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s028lbl.pdf
09/12/2023	SUPPL-26	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819Orig1s026lbl.pdf
03/13/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s022lbl.pdf
08/23/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s010lbl.pdf
06/17/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s020lbl.pdf
06/17/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf
05/11/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s015lbl.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf
02/04/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209819s009lbl.pdf
03/05/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf
11/30/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf

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