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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210136
Company: BRAEBURN

Medication Guide

REMS

Products on NDA 210136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIXADI	BUPRENORPHINE	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	No
BRIXADI	BUPRENORPHINE	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2023	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210136Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/210136Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s004correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210136Orig1s004correctedltr.pdf

Labels for NDA 210136

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s004correctedlbl.pdf
05/23/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf

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