DICLOFENAC SODIUM
Details
- Status
- Prescription
- First Approved
- 1995-06-29
- Routes
- TOPICAL, ORAL, OPHTHALMIC, INTRAVENOUS
- Dosage Forms
- GEL, SOLUTION, TABLET, DELAYED RELEASE, SOLUTION/DROPS, TABLET, EXTENDED RELEASE
Companies
DICLOFENAC SODIUM Approval History
What DICLOFENAC SODIUM Treats
1 indicationsDICLOFENAC SODIUM is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Arthritis
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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.
DICLOFENAC SODIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.