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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075203

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NDA 075203 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 075203

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

Pharmacology for NDA: 075203

Medical Subject Heading (MeSH) Categories for 075203

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 075203

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075203	ANDA	Actavis Pharma, Inc.	0591-0582	0591-0582-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0582-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Oct 24, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	225MG
Approval Date:	Oct 24, 2000	TE:	AB	RLD:	No

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