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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 018873

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NDA 018873 describes MEXITIL, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. Additional details are available on the MEXITIL profile page.

The generic ingredient in MEXITIL is mexiletine hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.

Summary for 018873

Tradename:	MEXITIL
Applicant:	Boehringer Ingelheim
Ingredient:	mexiletine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018873

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018873

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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