BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Details
- Status
- Prescription
- First Approved
- 1982-10-27
- Routes
- N/A
- Dosage Forms
- LIQUID
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER Approval History
What BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER Treats
1 FDA approvalsOriginally approved for its first indication in 1982 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 1982)
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.
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER FDA Label Details
ProIndications & Usage
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.