APPLICATION
ANDA074597
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-29
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
Approval history
2026-06-18REMS · Supplement 24AP
2024-10-31REMS · Supplement 21AP
2020-04-10Labeling · Supplement 18 · standardAP
2020-04-10Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15AP
2009-05-29Labeling · Supplement 7AP
2006-12-29Labeling · Supplement 5AP
2000-03-09Manufacturing (CMC) · Supplement 3AP
1998-09-25Manufacturing (CMC) · Supplement 1AP
1998-09-25Manufacturing (CMC) · Supplement 2AP
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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