APPLICATION
ANDA075523
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE EQ 0.5MG BASE, PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 11AP
2025-12-23Labeling · Supplement 10 · standardAP
2025-12-15Labeling · Supplement 8 · standardAP
2024-10-31REMS · Supplement 9AP
2023-12-15Labeling · Supplement 7 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-09Labeling · Supplement 5 · standardAP
2018-09-21Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 3AP
2017-03-31Labeling · Supplement 2 · standardAP
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.