← FDA DRUG APPROVALS

FDA NDA · NDA209819

SUBLOCADE

buprenorphine

Sponsor: INDIVIOR

APPLICATION
NDA209819
TYPE
NDA
ORIGINAL APPROVAL
2017-11-30
LATEST ACTION
2025-12-22
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

SUBLOCADE · ReferencePrescription
BUPRENORPHINE 100MG/0.5ML (100MG/0.5ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS
SUBLOCADE · ReferencePrescription
BUPRENORPHINE 300MG/1.5ML (200MG/ML) · SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2025-12-22Labeling · Supplement 37 · standard — Letter ↗AP
2025-04-11REMS · Supplement 34 — Letter ↗AP
2025-02-21Efficacy · Supplement 31 · priority — Label ↗AP
2024-04-19REMS · Supplement 29 — Letter ↗AP
2023-12-15Labeling · Supplement 28 · standard — Label ↗AP
2023-09-12Manufacturing (CMC) · Supplement 26 — Letter ↗AP
2023-07-03REMS · Supplement 24 — Letter ↗AP
2023-03-13Labeling · Supplement 22 · standard — Letter ↗AP
2023-01-06REMS · Supplement 21 — Letter ↗AP
2022-08-23Labeling · Supplement 10 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 20 · standard — Letter ↗AP
2021-09-22REMS · Supplement 19 — Letter ↗AP
2021-06-17Labeling · Supplement 18 · standard — Letter ↗AP
2021-05-11Labeling · Supplement 15 · standard — Label ↗AP
2021-03-04Labeling · Supplement 17 · standard — Label ↗AP
2020-06-15REMS · Supplement 16 — Letter ↗AP
2020-02-04Labeling · Supplement 12 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 9 · standard — Label ↗AP
2018-03-05Labeling · Supplement 1 · standard — Label ↗AP
2017-11-30Type 3 - New Dosage Form · Original · priority — Label ↗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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