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FDA NDA · NDA018565

INFUMORPH 200

morphine sulfate

Sponsor: HIKMA

APPLICATION
NDA018565
TYPE
NDA
ORIGINAL APPROVAL
1984-09-18
LATEST ACTION
2025-12-22
ROUTE
EPIDURAL, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DURAMORPH PF · ReferencePrescription
MORPHINE SULFATE 0.5MG/ML · INJECTABLE · INJECTION
INFUMORPH · ReferencePrescription
MORPHINE SULFATE 25MG/ML · INJECTABLE · INJECTION
DURAMORPH PF · ReferencePrescription
MORPHINE SULFATE 1MG/ML · INJECTABLE · INJECTION
INFUMORPH · ReferencePrescription
MORPHINE SULFATE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 35 · standard — Letter ↗AP
2025-12-22Labeling · Supplement 36 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 27 · standard — Label ↗AP
2023-12-15Labeling · Supplement 31 · standard — Label ↗AP
2023-12-15Labeling · Supplement 28 · standard — Label ↗AP
2023-12-15Labeling · Supplement 30 · standard — Label ↗AP
2023-11-08Labeling · Supplement 29 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 24 · standard — Label ↗AP
2016-12-16Labeling · Supplement 22 · standard — Letter ↗AP
2016-06-06Manufacturing (CMC) · Supplement 21 · priorityAP
2010-10-01Labeling · Supplement 20 · standard — Letter ↗AP
2005-06-06Labeling · Supplement 14 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 12 · standard — Letter ↗AP
2003-06-26Labeling · Supplement 10 · standard — Letter ↗AP
2001-12-07Labeling · Supplement 9 · standardAP
1999-06-14Manufacturing (CMC) · Supplement 8 · priorityAP
1998-04-17Manufacturing (CMC) · Supplement 7 · priorityAP
1997-02-12Manufacturing (CMC) · Supplement 6 · priorityAP
1994-04-28Labeling · Supplement 5AP
1991-07-19Manufacturing (CMC) · Supplement 2 · priorityAP
1991-07-19Labeling · Supplement 3AP
1989-05-03Labeling · Supplement 4AP
1985-08-22Labeling · Supplement 1AP
1984-09-18Type 3 - New Dosage Form · Original · priorityAP
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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