APPLICATION
ANDA076855
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-23
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 2MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 4MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 25AP
2025-03-13Labeling · Supplement 19 · standardAP
2025-03-13Labeling · Supplement 23 · standardAP
2024-10-31REMS · Supplement 22AP
2020-03-09Labeling · Supplement 14 · standardAP
2020-03-09Labeling · Supplement 12 · standardAP
2020-03-09Labeling · Supplement 17 · standardAP
2018-09-18REMS · Supplement 13AP
2008-02-06Labeling · Supplement 5AP
2006-11-09Labeling · Supplement 4AP
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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