← FDA DRUG APPROVALS

FDA NDA · NDA021078

MALARONE

atovaquone and proguanil hydrochloride

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA021078
TYPE
NDA
ORIGINAL APPROVAL
2000-07-14
LATEST ACTION
2026-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MALARONE PEDIATRIC · ReferencePrescription
ATOVAQUONE 62.5MG, PROGUANIL HYDROCHLORIDE 25MG · TABLET · ORAL
MALARONE · ReferencePrescription
ATOVAQUONE 250MG, PROGUANIL HYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2026-06-10Labeling · Supplement 26 · standard — Letter ↗AP
2026-03-23Labeling · Supplement 25 · standard — Label ↗AP
2019-02-22Labeling · Supplement 23 · standard — Letter ↗AP
2013-02-27Labeling · Supplement 22 · standard — Letter ↗AP
2009-09-02Labeling · Supplement 17 · standard — Letter ↗AP
2008-12-18Labeling · Supplement 16 · standard — Letter ↗AP
2008-05-07Labeling · Supplement 14 · standard — Label ↗AP
2007-12-04Labeling · Supplement 12 · standard — Letter ↗AP
2005-02-27Labeling · Supplement 8 · standard — Letter ↗AP
2005-02-27Labeling · Supplement 9 · standard — Letter ↗AP
2004-11-24Labeling · Supplement 7 · standard — Label ↗AP
2004-09-03Labeling · Supplement 2 · standard — Label ↗AP
2003-12-02Efficacy · Supplement 6 · priority — Label ↗AP
2003-05-09Supplement · Supplement 5 · priority — Review ↗AP
2002-08-02Efficacy · Supplement 3 · standard — Review ↗AP
2002-05-13Manufacturing (CMC) · Supplement 4 · priority — Review ↗AP
2002-02-28Labeling · Supplement 1 · standard — Review ↗AP
2000-07-14Type 4 - New Combination · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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