APPLICATION
ANDA077471
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-09
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 4MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 23AP
2024-11-19REMS · Supplement 20AP
2020-03-12Labeling · Supplement 9 · standardAP
2020-03-12Labeling · Supplement 16 · standardAP
2020-03-12Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 12AP
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.