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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215315

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NDA 215315 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Leading, Novast Labs, Senores Pharms, Teva, Watson Labs, and Zenara, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the MEXILETINE HYDROCHLORIDE profile page.

The generic ingredient in MEXILETINE HYDROCHLORIDE 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 215315

Tradename:	MEXILETINE HYDROCHLORIDE
Applicant:	Zenara
Ingredient:	mexiletine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 215315

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Aug 26, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Aug 26, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Aug 26, 2022	TE:	AB	RLD:	No

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