DEXTROSE 5% AND LACTATED RINGER'S (calcium chloride) · Fresenius Kabi
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories, as required by the clinical condition of the patient.
Details
- Status
- Prescription
- First Approved
- 2022-03-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
DEXTROSE 5% AND LACTATED RINGER'S Approval History
What DEXTROSE 5% AND LACTATED RINGER'S Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2022)Letter
Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
DEXTROSE 5% AND LACTATED RINGER'S FDA Label Details
Indications & Usage
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories, as required by the clinical condition of the patient.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.