Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212928

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NDA 212928 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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for 212928

Tradename:	PROPAFENONE HYDROCHLORIDE
Applicant:	Twi Pharms
Ingredient:	propafenone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 212928

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	225MG
Approval Date:	Jun 18, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	325MG
Approval Date:	Jun 18, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	425MG
Approval Date:	Jun 18, 2020	TE:		RLD:	No

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