An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm 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
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
12/15/2023	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

Top