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RYTHMOL Drug Profile

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Rythmol is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. It is available from one supplier.

The generic ingredient in RYTHMOL is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for Tradename: RYTHMOL

Suppliers / Packagers: see list1
Bulk Api Vendors: see list42
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details

Pharmacology for Tradename: RYTHMOL

Drug ClassAntiarrhythmic
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
propafenone hydrochloride
TABLET;ORAL019151-001Nov 27, 1989RXNo► subscribe► subscribe
Glaxosmithkline Llc
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-001Sep 4, 2003RXNo► subscribe► subscribe
Glaxosmithkline Llc
propafenone hydrochloride
TABLET;ORAL019151-003Nov 20, 1992RXNo► subscribe► subscribe
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Paragraph IV activity for: RYTHMOL

Drugname Dosage Strength RLD Submissiondate
propafenoneExtended-release Capsules325 mgRythmol SR11/7/2006
propafenone hydrochlorideExtended-release Capsules225 mg and 425 mgRythmol SR10/11/2006
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