RYTHMOL (propafenone hydrochloride) · GSK
RYTHMOL is FDA-approved to treat 5 conditions (same as PROPAFENONE HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1989-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET
RYTHMOL Approval History
What RYTHMOL Treats
5 indicationsRYTHMOL is approved for 5 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atrial Fibrillation
- Atrial Flutter
- Supraventricular Tachycardia
- Ventricular Tachycardia
- Ventricular Arrhythmias
Same approved indications as PROPAFENONE HYDROCHLORIDE (same active ingredient).
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
RYTHMOL FDA Label Details
Indications & Usage
FDA Label (PDF)RYTHMOL is FDA-approved to treat 5 conditions — same approved indications as PROPAFENONE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.