Last Updated: August 2, 2026

Details for New Drug Application (NDA): 202688

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NDA 202688 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma Intl, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the PROPAFENONE HYDROCHLORIDE profile page.

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

Summary for 202688

Tradename:	PROPAFENONE HYDROCHLORIDE
Applicant:	Watson Labs Inc
Ingredient:	propafenone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 202688

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	225MG
Approval Date:	Aug 24, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	325MG
Approval Date:	Aug 24, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	425MG
Approval Date:	Aug 24, 2015	TE:	AB	RLD:	No

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