Last Updated: August 9, 2026

Details for New Drug Application (NDA): 089027

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NDA 089027 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 089027

Tradename:	PROCAINAMIDE HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	procainamide hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 089027

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Oct 22, 1985	TE:		RLD:	No

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