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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074377

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NDA 074377 describes MEXILETINE HYDROCHLORIDE, which is a drug marketed by Idt Australia Ltd, Teva, and Watson Labs, and is included in four NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.
Summary for 074377
Ingredient:mexiletine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074377
Medical Subject Heading (MeSH) Categories for 074377
Suppliers and Packaging for NDA: 074377
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074377 ANDA Teva Pharmaceuticals USA, Inc. 0093-8739 N 0093-8739-01
MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074377 ANDA Teva Pharmaceuticals USA, Inc. 0093-8740 N 0093-8740-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:May 16, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:May 16, 1995TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:May 16, 1995TE:RLD:No

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