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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076523

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NDA 076523 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hikma Intl Pharms, Sandoz, 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

Pharmacology for NDA: 076523

Medical Subject Heading (MeSH) Categories for 076523

Antimalarials

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	Hikma Pharmaceuticals USA Inc.	0054-0025	0054-0025-11	1 BOTTLE in 1 CARTON (0054-0025-11) / 25 TABLET in 1 BOTTLE

Profile for product number 001

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

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