Details for New Drug Application (NDA): 021416

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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. Twenty 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

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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	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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