Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

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. Eighteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021416
Medical Subject Heading (MeSH) Categories for 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)
Paragraph IV (Patent) Challenges for 021416
Tradename Dosage Ingredient NDA Submissiondate
RYTHMOL SR CAPSULE, EXTENDED RELEASE;ORAL propafenone hydrochloride 021416 2006-11-07
RYTHMOL SR CAPSULE, EXTENDED RELEASE;ORAL propafenone hydrochloride 021416 2006-10-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Sep 4, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Sep 4, 2003TE:ABRLD:Yes

Profile for product number 003

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

Expired US 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;ORAL 021416-001 Sep 4, 2003   Start Trial   Start Trial
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003   Start Trial   Start Trial
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-002 Sep 4, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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