APPLICATION
ANDA074137
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-03
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-12-22Labeling · Supplement 43 · standardAP
2024-06-12Labeling · Supplement 16 · standardAP
2024-06-12Labeling · Supplement 36 · standardAP
2024-06-12Labeling · Supplement 28 · standardAP
2024-06-12Labeling · Supplement 40 · standardAP
2005-07-21Labeling · Supplement 8AP
2003-02-05Labeling · Supplement 5AP
2001-02-14Manufacturing (CMC) · Supplement 3AP
1996-12-02Manufacturing (CMC) · Supplement 2AP
1996-12-02Manufacturing (CMC) · Supplement 1AP
1996-06-03OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.