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Generated: May 23, 2018

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Details for New Drug Application (NDA): 076523

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NDA 076523 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma Intl Pharms, Sandoz, Us Army Walter Reed, and West-ward Pharms Int, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the MEFLOQUINE HYDROCHLORIDE profile page.

The generic ingredient in MEFLOQUINE HYDROCHLORIDE is mefloquine hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
Summary for 076523
Applicant:West-ward Pharms Int
Ingredient:mefloquine hydrochloride
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076523
Medical Subject Heading (MeSH) Categories for 076523
Suppliers and Packaging for NDA: 076523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 076523 ANDA West-Ward Pharmaceuticals Corp. 0054-0025 N 0054-0025-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 1, 2004TE:ABRLD:No

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