APPLICATION
ANDA204278
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-06
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 32MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 12MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 16MG · TABLET, EXTENDED RELEASE · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 25AP
2025-12-22Labeling · Supplement 24 · standardAP
2025-10-01Labeling · Supplement 22 · standardAP
2024-10-31REMS · Supplement 23AP
2023-12-15Labeling · Supplement 21 · standardAP
2023-05-22Labeling · Supplement 17 · standardAP
2021-03-04Labeling · Supplement 16 · standardAP
2021-02-26Labeling · Supplement 14 · standardAP
2021-02-26Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 12AP
2017-10-20Labeling · Supplement 2 · standardAP
2017-05-26REMS · Supplement 11AP
2017-02-17Manufacturing (CMC) · Supplement 8 · unknownAP
2016-09-30REMS · Supplement 6AP
2016-04-20REMS · Supplement 3AP
2015-06-26REMS · Supplement 1AP
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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