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FDA NDA · NDA019591

LARIAM

Sponsor: ROCHE

APPLICATION
NDA019591
TYPE
NDA
ORIGINAL APPROVAL
1989-05-02
LATEST ACTION
2011-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LARIAM · ReferenceDiscontinued
MEFLOQUINE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-04-29Labeling · Supplement 30 · standard — Review ↗AP
2009-08-20Labeling · Supplement 28 · standard — Medication Guide ↗AP
2009-08-20Labeling · Supplement 26 · standard — Review ↗AP
2009-06-26Labeling · Supplement 27 · standard — Review ↗AP
2008-09-23Labeling · Supplement 25 · standard — Review ↗AP
2008-09-23Labeling · Supplement 24 · standard — Letter ↗AP
2008-05-12Labeling · Supplement 23 · standard — Review ↗AP
2003-08-20Labeling · Supplement 22 · standard — Review ↗AP
2003-07-09Labeling · Supplement 19 · standard — Letter ↗AP
2003-01-10Labeling · Supplement 17 · standard — Review ↗AP
2003-01-10Labeling · Supplement 14 · standard — Review ↗AP
2002-10-03Labeling · Supplement 20 · standard — Review ↗AP
2002-06-21Manufacturing (CMC) · Supplement 18 · standardAP
2002-03-24Manufacturing (CMC) · Supplement 15 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 13 · standardAP
1999-08-02Labeling · Supplement 12 · standardAP
1999-08-02Labeling · Supplement 10 · standardAP
1998-10-20Manufacturing (CMC) · Supplement 11 · standardAP
1997-08-06Labeling · Supplement 7 · standardAP
1996-01-22Manufacturing (CMC) · Supplement 9 · standardAP
1995-06-16Manufacturing (CMC) · Supplement 8 · standardAP
1993-11-03Manufacturing (CMC) · Supplement 6 · standardAP
1993-11-02Labeling · Supplement 5 · standardAP
1992-11-23Efficacy · Supplement 3 · standardAP
1991-10-04Manufacturing (CMC) · Supplement 4 · standardAP
1990-07-30Manufacturing (CMC) · Supplement 2 · standardAP
1990-02-02Labeling · Supplement 1 · standardAP
1989-05-02Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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