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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 084604

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NDA 084604 describes PROCAINAMIDE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Abraxis Pharm, Caplin, Gland, Hikma, Hospira, Intl Medication, Nexus, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, and Sandoz, and is included in sixty NDAs. It is available from eleven suppliers. Additional details are available on the PROCAINAMIDE HYDROCHLORIDE profile page.

The generic ingredient in PROCAINAMIDE HYDROCHLORIDE is procainamide hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.

Summary for 084604

Tradename:	PROCAINAMIDE HYDROCHLORIDE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	procainamide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084604

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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