APPLICATION
ANDA212133
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-23
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 16MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 32MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 12MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 13AP
2025-12-22Labeling · Supplement 8 · standardAP
2025-10-09Labeling · Supplement 4 · standardAP
2024-10-31REMS · Supplement 5AP
2023-12-15Labeling · Supplement 2 · standardAP
2023-12-15Labeling · Supplement 3 · 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.