Last Updated: September 24, 2026

Details for New Drug Application (NDA): 019753

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NDA 019753 describes ETHMOZINE, which is a drug marketed by Shire and is included in one NDA. Additional details are available on the ETHMOZINE profile page.

The generic ingredient in ETHMOZINE is moricizine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the moricizine hydrochloride profile page.

Summary for 019753

Tradename:	ETHMOZINE
Applicant:	Shire
Ingredient:	moricizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019753

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jun 19, 1990	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 19, 1990	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jun 19, 1990	TE:		RLD:	No

Expired US Patents for NDA 019753

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-001	Jun 19, 1990	3,740,395	⤷ Start Trial
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990	3,864,487	⤷ Start Trial
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990	3,740,395	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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