STERILE WATER
Details
- Status
- Prescription
- First Approved
- 1974-12-31
- Routes
- INJECTION, IRRIGATION
- Dosage Forms
- INJECTABLE, LIQUID
STERILE WATER Approval History
What STERILE WATER Treats
2 FDA approvalsOriginally approved for its first indication in 1974 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 1974)
- • Approved indication (Aug 2006)
STERILE WATER Boxed Warning
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES....
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
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.
STERILE WATER FDA Label Details
ProIndications & Usage
FDA Label (PDF)Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.
Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.