TheraRadar
Data updated: Jun 17, 2026

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER (calcium chloride)

Other Approved 1984-11-30

Ringer’s Injection helps patients by providing a necessary source of water and electrolytes. It is used for both adult and pediatric patients who require fluid replenishment and mineral support. This solution helps maintain the body's internal balance by delivering essential ions required for various physiological processes.

Source: FDA Label • Fresenius Kabi

How DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER Works

This injection works by supplying the body with key electrolytes, including sodium, potassium, chloride, and calcium. Sodium and chloride help regulate fluid distribution and acid-base balance, while potassium and calcium are vital for nerve conduction, muscle contraction, and normal heart function. Together, these components support the framework of bones and the functional mechanisms of blood clotting.

1
Indication
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1984-11-30
Routes
INTRAPERITONEAL
Dosage Forms
SOLUTION

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER Approval History

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Original
New Indication
New Form
Label Update
43 FDA actions from 1984 to 2021
Jan 2021 SUPPL
Label · Labeling
Jul 2016 SUPPL
Mfg · Manufacturing (CMC)
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)

What DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER Treats

2 indications

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Electrolyte deficiency
  • Dehydration
Source: FDA Label

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
CALCIUM CHLORIDE
2 shared
Fresenius Kabi
Shared indications:
Electrolyte deficiencyDehydration
AMPHADASE
HYALURONIDASE
1 shared
AMPHASTAR PHARM
Shared indications:
Dehydration
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
CALCIUM CHLORIDE
1 shared
Pfizer
Shared indications:
Electrolyte deficiency

Fresenius Kabi's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

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Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT07550413 20042026 Ph 2 not yet recruiting Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
NCT03772990 ICARUS 21/2019 Ph 4 completed Calcium Administration in Cardiac Surgery
NCT05027048 CALBLOC results posted 62206 MRTG-02-15-2022-Ansari, YIG-2020 Ph 3 completed Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
NCT04153435 COCA results posted 00002 2019-003387-46 Ph 2 completed Calcium for Out-of-Hospital Cardiac Arrest
NCT03867383 results posted 43076 Ph 1, Ph 2 completed Calcium Chloride for Prevention of Uterine Atony During Cesarean
NCT01941914 AA1310 Ph 1 completed Calcium Electroporation for the Treatment of Keloids
NCT00955266 results posted 2009-P-000052 Ph 4 terminated A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER is indicated for the treatment of Electrolyte deficiency; Dehydration.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.