Is there a generic for Mefloquine hydrochloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Mefloquine hydrochloride, referencing the brand LARIAM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mefloquine hydrochloride?

LARIAM (NDA 019591, ROCHE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mefloquine hydrochloride are approved?

Mefloquine hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Mefloquine hydrochloride

Mefloquine hydrochloride is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LARIAM · NDA 019591

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
LARIAMRLD	ROCHE	NDA 019591	—	May 02, 1989
MEFLOQUINE HYDROCHLORIDE	US ARMY WALTER REED	NDA 019578	—	May 02, 1989

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
MEFLOQUINE HYDROCHLORIDE	HIKMA INTL PHARMS	ANDA 077699	—	Apr 21, 2010
MEFLOQUINE HYDROCHLORIDE	HIKMA	ANDA 076523	—	Oct 01, 2004
MEFLOQUINE HYDROCHLORIDE	BARR	ANDA 076392	AB	Dec 29, 2003
MEFLOQUINE HYDROCHLORIDE	CHARTWELL RX	ANDA 076175	AB	Feb 20, 2002

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Mefloquine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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