SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Details
- Status
- Prescription
- First Approved
- 1970-08-12
- Routes
- INJECTION, IRRIGATION
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Approval History
What SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Treats
24 FDA approvalsOriginally approved for its first indication in 1970 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Aug 1970)
- • Approved indication (Dec 1970)
- • Approved indication (Feb 1972)
- • Approved indication (Apr 1974)
- • Approved indication (Dec 1974)
- • Approved indication (Feb 1978)
- • Approved indication (Feb 1980)
- • Approved indication (May 1980)
- • Approved indication (Oct 1982)
- • Approved indication (Jul 1984)
- • Approved indication (Jan 1985)
- • Approved indication (Jul 1985)
- • Approved indication (Sep 1985)
- • Approved indication (Mar 1988)
- • Approved indication (Dec 1992)
- • Approved indication (Oct 2004)
- • Approved indication (Jul 2006)Label Letter
- • Approved indication (Aug 2006)
- • Approved indication (Apr 2007)
- • Approved indication (May 2016)Letter
- • Approved indication (May 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2024)
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.
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA Label Details
ProIndications & Usage
FDA Label (PDF)This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.