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FDA NDA · NDA020631

MORPHINE SULFATE

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APPLICATION
NDA020631
TYPE
NDA
ORIGINAL APPROVAL
1996-07-03
LATEST ACTION
2023-12-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 1MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATEDiscontinued
MORPHINE SULFATE 2MG/ML · INJECTABLE · INJECTION

Approval history

2023-12-15Labeling · Supplement 3 · standard — Label ↗AP
2019-10-07Labeling · Supplement 2 · standard — Label ↗AP
2016-12-16Labeling · Supplement 1 · standard — Letter ↗AP
1996-07-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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