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FDA NDA · NDA210136

BRIXADI

buprenorphine

Sponsor: BRAEBURN

APPLICATION
NDA210136
TYPE
NDA
ORIGINAL APPROVAL
2023-05-23
LATEST ACTION
2025-12-22
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

BRIXADI · ReferencePrescription
BUPRENORPHINE 96MG/0.27ML (356MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 32MG/0.64ML (50MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 16MG/0.32ML (50MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 128MG/0.36ML (356MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 64MG/0.18ML (356MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 24MG/0.48ML (50MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
BRIXADI · ReferencePrescription
BUPRENORPHINE 8MG/0.16ML (50MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2025-12-22Labeling · Supplement 12 · standard — Letter ↗AP
2025-08-29REMS · Supplement 11 — Letter ↗AP
2025-03-28REMS · Supplement 8 — Letter ↗AP
2023-12-15Labeling · Supplement 4 · standard — Label ↗AP
2023-05-23Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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