← FDA DRUG APPROVALS

FDA NDA · NDA202515

MORPHINE SULFATE

Sponsor: HOSPIRA INC

APPLICATION
NDA202515
TYPE
NDA
ORIGINAL APPROVAL
2011-11-14
LATEST ACTION
2025-12-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 50MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 10MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 4MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferenceDiscontinued
MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 8MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATE · ReferencePrescription
MORPHINE SULFATE 2MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 46 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 37 · standard — Label ↗AP
2022-04-28Labeling · Supplement 33 · standard — Letter ↗AP
2021-04-29Efficacy · Supplement 25 · standard — Label ↗AP
2020-08-17Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2019-10-07Labeling · Supplement 17 · standard — Label ↗AP
2016-12-16Labeling · Supplement 6 · standard — Label ↗AP
2013-08-14Manufacturing (CMC) · Supplement 3 · standardAP
2011-11-14Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →