ORPHENGESIC
Details
- Status
- Prescription
- First Approved
- 1998-05-29
- Routes
- ORAL
- Dosage Forms
- TABLET
ORPHENGESIC Approval History
What ORPHENGESIC Treats
2 indicationsORPHENGESIC is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Headache
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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.
ORPHENGESIC FDA Label Details
ProIndications & Usage
Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.