Last Updated: May 10, 2026

Details for New Drug Application (NDA): 219987


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NDA 219987 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Ingenus Pharms Llc, Macleods Pharms Ltd, Quagen, Rising, Senores Pharms, Teva, and Watson Labs, and is included in eleven 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 219987
Tradename:MEXILETINE HYDROCHLORIDE
Applicant:Macleods Pharms Ltd
Ingredient:mexiletine hydrochloride
Patents:0
Pharmacology for NDA: 219987
Medical Subject Heading (MeSH) Categories for 219987
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Suppliers and Packaging for NDA: 219987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 219987 ANDA Macleods Pharmaceuticals Limited 33342-555 33342-555-11 100 CAPSULE in 1 CONTAINER (33342-555-11)
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 219987 ANDA Macleods Pharmaceuticals Limited 33342-555 33342-555-12 10 BLISTER PACK in 1 CARTON (33342-555-12) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Mar 23, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 23, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Mar 23, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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