RecallHawk

INFUMORPH 200 (MORPHINE SULFATE)

HIKMA

Summary

FDA approved INFUMORPH 200 (MORPHINE SULFATE) by HIKMA. NDA (New Drug) approval (Labeling) on 2025-12-22. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

NDA018565-35

Action Date

2025-12-22

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

INFUMORPH 200 (generic: MORPHINE SULFATE), INJECTABLE, INJECTION. Application: NDA018565

Company

Context & Analysis

HIKMA has 117 FDA actions in our database.

Frequently Asked Questions

How often does HIKMA have FDA actions?

HIKMA has 117 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA018565-35" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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