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FDA NDA · NDA019916

MORPHINE SULFATE

Sponsor: ICU MEDICAL INC

APPLICATION
NDA019916
TYPE
NDA
ORIGINAL APPROVAL
1992-10-30
LATEST ACTION
2019-10-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MORPHINE SULFATE · ReferenceDiscontinued
MORPHINE SULFATE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferenceDiscontinued
MORPHINE SULFATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2019-10-07Labeling · Supplement 19 · standard — Label ↗AP
2016-12-16Labeling · Supplement 16 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 17 · standard — Letter ↗AP
2016-03-09Manufacturing (CMC) · Supplement 15 · standardAP
2008-03-18Manufacturing (CMC) · Supplement 10AP
2006-10-27Manufacturing (CMC) · Supplement 4 — Label ↗AP
1996-01-19Manufacturing (CMC) · Supplement 1 · standardAP
1992-10-30Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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