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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 076523

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NDA 076523 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Chartwell Rx, Hikma, Hikma Intl Pharms, and Us Army Walter Reed, and is included in five NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.

Summary for 076523

Tradename:	MEFLOQUINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	mefloquine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 076523

Antimalarials

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 1, 2004	TE:		RLD:	No

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