← FDA DRUG APPROVALS

FDA NDA · NDA019891

DILAUDID

hydromorphone hydrochloride

Sponsor: RHODES PHARMS

APPLICATION
NDA019891
TYPE
NDA
ORIGINAL APPROVAL
1992-12-07
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 35 — Letter ↗AP
2025-12-22Labeling · Supplement 34 · standard — Letter ↗AP
2024-10-31REMS · Supplement 33 — Letter ↗AP
2023-12-15Labeling · Supplement 31 · standard — Label ↗AP
2021-03-04Labeling · Supplement 29 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 28 · standard — Label ↗AP
2018-09-18Labeling · Supplement 27 · standard — Label ↗AP
2018-09-18REMS · Supplement 26 — Label ↗AP
2016-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2016-02-12Manufacturing (CMC) · Supplement 21 · standardAP
2016-02-12Manufacturing (CMC) · Supplement 22 · standardAP
2016-02-05Manufacturing (CMC) · Supplement 23 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 20 · standardAP
2015-02-16Manufacturing (CMC) · Supplement 19 · standardAP
2013-11-14Manufacturing (CMC) · Supplement 16 · standardAP
2006-06-12Labeling · Supplement 8 · standard — Label ↗AP
2003-03-10Labeling · Supplement 2 · standardAP
2001-08-22Labeling · Supplement 4 · standardAP
1999-11-24Manufacturing (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 ↗

Related on SPEQ

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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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