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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076175

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NDA 076175 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 four 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. Four suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.

Summary for 076175

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

Pharmacology for NDA: 076175

Medical Subject Heading (MeSH) Categories for 076175

Antimalarials

Suppliers and Packaging for NDA: 076175

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175	ANDA	Chartwell RX, LLC	62135-973	62135-973-11	5 TABLET in 1 BOTTLE (62135-973-11)
MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175	ANDA	Chartwell RX, LLC	62135-973	62135-973-25	25 TABLET in 1 BOTTLE (62135-973-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 20, 2002	TE:		RLD:	No

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