APPLICATION
ANDA078331
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-27
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUPRENORPHINE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-12-22Labeling · Supplement 10 · standardAP
2025-12-22Labeling · Supplement 11 · standardAP
2020-06-23Labeling · Supplement 9 · standardAP
2020-06-23Labeling · Supplement 7 · standardAP
2007-03-27OriginalAP
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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