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LARIAM

NDA

MEFLOQUINE HYDROCHLORIDE | N019591 | HOFFMANN LA ROCHE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

PORTON PHARMA SOLUTIONS LTDMEFLOQUINE HYDROCHLORIDE

DMF 154132001

OLON SPAMEFLOQUINE HYDROCHLORIDE

DMF 156872001

SIEGFRIED EVIONNAZ SAMEFLOQUINE HYDROCHLORIDE

DMF 161272002

KNOLL AGInactiveMEFLOQUINE HYDROCHLORIDE

DMF 75491988

EMCURE PHARMACEUTICALS LTDInactiveMEFLOQUINE HYDROCHLORIDE USP

DMF 221382008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveMEFLOQUINE HYDROCHLORIDE

DMF 268832013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
May 4, 2011	SUPPL -30	View Letter (PDF)
Nov 19, 2009	SUPPL -28	View Letter (PDF)
Nov 19, 2009	SUPPL -26	View Letter (PDF)
Jun 30, 2009	SUPPL -27	View Letter (PDF)
Sep 26, 2008	SUPPL -25	View Letter (PDF)
Sep 26, 2008	SUPPL -24	View Letter (PDF)
May 14, 2008	SUPPL -23	View Letter (PDF)
Sep 8, 2003	SUPPL -22	View Letter (PDF)
Jul 10, 2003	SUPPL -19	View Letter (PDF)
Jan 10, 2003	SUPPL -17	View Letter (PDF)
Jan 10, 2003	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 2, 1989

No patent or exclusivity listings for this strength.