NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
Details
- Status
- Prescription
- First Approved
- 1975-08-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER Approval History
What NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER Treats
1 FDA approvalsOriginally approved for its first indication in 1975 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 1975)
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.
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details
ProIndications & Usage
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration .] ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See the device operator's manual for additional information and complete usage instructions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.