TheraRadar
Data updated: May 26, 2026

RYTHMOL SR (propafenone hydrochloride)

Cardiovascular Approved 2003-09-04
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Discontinued
First Approved
2003-09-04
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

GSK
Active Ingredient: PROPAFENONE HYDROCHLORIDE

RYTHMOL SR Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2003 to 2018
Nov 2018 SUPPL
Label · Labeling
FDA Letter Label
Jul 2014 SUPPL
Mfg · Manufacturing (CMC)
Sep 2013 SUPPL
Mfg · Manufacturing (CMC)

What RYTHMOL SR Treats

1 FDA approvals

Originally approved for its first indication in 2003 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 SR FDA Label Details

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Data Sources

FDA Approval: NDA021416 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.