APPLICATION
ANDA202144
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-12
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 16MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 32MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 12MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 23AP
2025-12-22Labeling · Supplement 22 · standardAP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 21AP
2023-12-15Labeling · Supplement 19 · standardAP
2021-03-04Labeling · Supplement 18 · standardAP
2021-03-04Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15AP
2017-11-07Labeling · Supplement 14 · standardAP
2017-05-26REMS · Supplement 13AP
2016-09-30REMS · Supplement 10AP
2016-04-20REMS · Supplement 8AP
2015-06-26REMS · Supplement 7AP
2014-08-19REMS · Supplement 5AP
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.