APPLICATION
ANDA076931
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-02
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 16 · standardAP
2020-06-15Labeling · Supplement 12 · standardAP
2019-07-12Manufacturing (CMC) · Supplement 11 · unknownAP
2005-03-02OriginalAP
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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