← FDA DRUG APPROVALS

FDA NDA · NDA019034

HYDROMORPHONE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA019034
TYPE
NDA
ORIGINAL APPROVAL
1984-01-11
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

DILAUDID-HPDiscontinued
HYDROMORPHONE HYDROCHLORIDE 250MG/VIAL · INJECTABLE · INJECTION
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML · INJECTABLE · INJECTION
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 4MG/ML · INJECTABLE · INJECTION
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
DILAUDID-HP · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML · INJECTABLE · INJECTION
DILAUDID · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 48 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 46 · standard — Label ↗AP
2020-01-16Manufacturing (CMC) · Supplement 37 · standard — Label ↗AP
2019-10-07Labeling · Supplement 35 · standard — Label ↗AP
2018-01-26Labeling · Supplement 30 · standardAP
2017-02-10Manufacturing (CMC) · Supplement 29 — Label ↗AP
2016-12-16Labeling · Supplement 27 · standard — Letter ↗AP
2016-12-16Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2011-06-30Labeling · Supplement 21 · unknown — Letter ↗AP
2009-04-30Efficacy · Supplement 18 · unknown — Label ↗AP
2006-06-12Labeling · Supplement 12 · standard — Label ↗AP
2001-11-09Manufacturing (CMC) · Supplement 9 · priorityAP
2001-07-18Labeling · Supplement 8 · standardAP
1994-08-08Manufacturing (CMC) · Supplement 7 · priorityAP
1994-08-04Labeling · Supplement 6AP
1991-10-16Manufacturing (CMC) · Supplement 4 · priorityAP
1991-10-16Manufacturing (CMC) · Supplement 5 · priorityAP
1984-02-29Labeling · Supplement 1AP
1984-01-11Type 3 - New Dosage Form · Original · priorityAP
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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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