Is Procainamide approved by the US FDA?

Drugs@FDA lists 79 application product lines for Procainamide, including PROCAINAMIDE HYDROCHLORIDE (Prescription); PROCAINAMIDE HYDROCHLORIDE (Prescription); PROCAINAMIDE HYDROCHLORIDE (Prescription); PROCAINAMIDE HYDROCHLORIDE (Prescription); PROCAINAMIDE HYDROCHLORIDE (Prescription).

Active substance

Procainamide

US FDA 79
Health Canada 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PROCAINAMIDE HYDROCHLORIDE	100MG/ML	injectable · injection	INTL MEDICATION	Prescription	31 Jul 1984
PROCAINAMIDE HYDROCHLORIDE	100MG/ML	injectable · injection	HOSPIRA	Prescription	12 Feb 1986
PROCAINAMIDE HYDROCHLORIDE	100MG/ML; 500MG/ML	injectable · injection	NEXUS	Prescription	13 Oct 2017
PROCAINAMIDE HYDROCHLORIDE	100MG/ML; 500MG/ML	injectable · injection	GLAND	Prescription	22 Jul 2024
PROCAINAMIDE HYDROCHLORIDE	100MG/ML; 500MG/ML	injectable · injection	CAPLIN	Prescription	4 Feb 2025
PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	APOTHECON	Discontinued	2 Jun 1950
PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	APOTHECON	Discontinued	2 Jun 1950
PRONESTYL	250MG; 375MG; 500MG	tablet · oral	APOTHECON	Discontinued	28 Feb 1974
PROCAINAMIDE HYDROCHLORIDE	250MG	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	2 Dec 1976
PROCAINAMIDE HYDROCHLORIDE	250MG	capsule · oral	LANNETT	Discontinued	11 May 1977
PROCAINAMIDE HYDROCHLORIDE	500MG	capsule · oral	LANNETT	Discontinued	11 May 1977
PROCAINAMIDE HYDROCHLORIDE	250MG	capsule · oral	WATSON LABS	Discontinued	3 Jun 1977
PROCAINAMIDE HYDROCHLORIDE	375MG	capsule · oral	WATSON LABS	Discontinued	3 Jun 1977
PROCAINAMIDE HYDROCHLORIDE	500MG	capsule · oral	WATSON LABS	Discontinued	7 Jun 1977
PROCAINAMIDE HYDROCHLORIDE	375MG	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	14 Jun 1977
PROCAINAMIDE HYDROCHLORIDE	500MG	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	14 Jun 1977
PROCAN SR	250MG	tablet, extended release · oral	PARKE DAVIS	Discontinued	11 Dec 1979
PROCAINAMIDE HYDROCHLORIDE	250MG	capsule · oral	WATSON LABS	Discontinued	17 Jul 1980
PROCAINAMIDE HYDROCHLORIDE	375MG	capsule · oral	WATSON LABS	Discontinued	17 Jul 1980
PROCAINAMIDE HYDROCHLORIDE	500MG	capsule · oral	WATSON LABS	Discontinued	17 Jul 1980
PRONESTYL-SR	500MG	tablet, extended release · oral	APOTHECON	Discontinued	12 Aug 1981
PROCAINAMIDE HYDROCHLORIDE	250MG	capsule · oral	VANGARD	Discontinued	1 Jun 1982
PROCAINAMIDE HYDROCHLORIDE	500MG	capsule · oral	VANGARD	Discontinued	1 Jun 1982
PROCAINAMIDE HYDROCHLORIDE	500MG/ML	injectable · injection	INTL MEDICATION	Discontinued	31 Jul 1984
PROCAN SR	1GM	tablet, extended release · oral	PARKEDALE	Discontinued	16 Jan 1985

54 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PROCAINAMIDE HYDROCHLORIDE INJECTION USP	02184486	100 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.