Details for New Drug Application (NDA): 021416

✉ Email this page to a colleague

NDA 021416 describes RYTHMOL SR, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the RYTHMOL SR profile page.

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

Summary for 021416

Tradename:	RYTHMOL SR
Applicant:	Glaxosmithkline Llc
Ingredient:	propafenone hydrochloride
Patents:	0

Pharmacology for NDA: 021416

Medical Subject Heading (MeSH) Categories for 021416

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 021416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416	NDA	GlaxoSmithKline LLC	0173-0823	0173-0823-18	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0823-18)
RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416	NDA	GlaxoSmithKline LLC	0173-0824	0173-0824-18	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0824-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	225MG
Approval Date:	Sep 4, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	325MG
Approval Date:	Sep 4, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	425MG
Approval Date:	Sep 4, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021416

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-001	Sep 4, 2003	⤷ Subscribe	⤷ Subscribe
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003	⤷ Subscribe	⤷ Subscribe
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.