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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 076193

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NDA 076193 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 fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for 076193

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

Medical Subject Heading (MeSH) Categories for 076193

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Feb 7, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	225MG
Approval Date:	Feb 7, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 7, 2002	TE:		RLD:	No

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