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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216463


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NDA 216463 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Leading, Novast Labs, Rising, Senores Pharms, Teva, and Watson Labs, 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 216463
Tradename:MEXILETINE HYDROCHLORIDE
Applicant:Annora Pharma
Ingredient:mexiletine hydrochloride
Patents:0
Pharmacology for NDA: 216463
Medical Subject Heading (MeSH) Categories for 216463
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Suppliers and Packaging for NDA: 216463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 216463 ANDA Camber Pharmaceuticals, Inc. 31722-036 31722-036-01 100 CAPSULE in 1 BOTTLE (31722-036-01)
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 216463 ANDA Camber Pharmaceuticals, Inc. 31722-037 31722-037-01 100 CAPSULE in 1 BOTTLE (31722-037-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Nov 9, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Nov 9, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Nov 9, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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