← FDA DRUG APPROVALS

FDA NDA · NDA019892

DILAUDID

hydromorphone hydrochloride

Sponsor: RHODES PHARMS

APPLICATION
NDA019892
TYPE
NDA
ORIGINAL APPROVAL
1992-12-07
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 2MG · TABLET · ORAL
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET · ORAL
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 4MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 44 — Letter ↗AP
2025-12-22Labeling · Supplement 43 · standard — Letter ↗AP
2024-10-31REMS · Supplement 42 — Letter ↗AP
2023-12-15Labeling · Supplement 41 · standard — Medication Guide ↗AP
2021-03-04Labeling · Supplement 37 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 35 · standard — Label ↗AP
2018-09-18Labeling · Supplement 34 · standard — Label ↗AP
2018-09-18REMS · Supplement 33 — Label ↗AP
2016-12-16Labeling · Supplement 29 · standard — Letter ↗AP
2015-01-26Manufacturing (CMC) · Supplement 25 · standardAP
2013-07-05Manufacturing (CMC) · Supplement 23 · standardAP
2013-01-24Manufacturing (CMC) · Supplement 19 · standardAP
2012-12-18Manufacturing (CMC) · Supplement 21 · standardAP
2007-11-09Manufacturing (CMC) · Supplement 15 — Label ↗AP
2006-06-12Labeling · Supplement 9 · standard — Label ↗AP
2003-03-10Labeling · Supplement 2 · standard — Letter ↗AP
2001-08-22Labeling · Supplement 4 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 6 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 7 · standardAP
2000-02-24Manufacturing (CMC) · Supplement 3 · standardAP
1995-03-31Labeling · Supplement 1 · standardAP
1992-12-07Type 3 - New Dosage Form · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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