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FDA NDA · NDA204223

MORPHINE SULFATE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA204223
TYPE
NDA
ORIGINAL APPROVAL
2013-10-30
LATEST ACTION
2026-05-29
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

MORPHINE SULFATE · ReferenceDiscontinued
MORPHINE SULFATE 8MG/ML (8MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 4MG/ML (4MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 10MG/ML (10MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MORPHINE SULFATE · ReferenceDiscontinued
MORPHINE SULFATE 5MG/ML (5MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 2MG/ML (2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS

Approval history

2026-05-29Labeling · Supplement 29 · standard — Label ↗AP
2025-12-22Labeling · Supplement 28 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 25 · standard — Label ↗AP
2019-10-07Labeling · Supplement 15 · standard — Letter ↗AP
2017-01-27Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 6 · standard — Letter ↗AP
2015-03-03Manufacturing (CMC) · Supplement 4 · standardAP
2014-11-16Manufacturing (CMC) · Supplement 3 · standardAP
2014-06-23Manufacturing (CMC) · Supplement 1 · standardAP
2013-10-30Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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