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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 two suppliers. 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 NDA: 021416

Tradename:
RYTHMOL SR
Applicant:
Glaxosmithkline Llc
Ingredient:
propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021416

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Sep 4, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Sep 4, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Sep 4, 2003TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 021416

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-001Sep 4, 20035,681,588► subscribe
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-003Sep 4, 20035,681,588► subscribe
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-002Sep 4, 20035,681,588► subscribe
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