FDA Approval Activities for this Drug…

Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline NDA 21-078/S3 8/2/02 8/12/02 8/5/02 Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline NDA 21-078/S1 2/28/02 3/7/02 Malarone (atovaquone and proguanil hydrochloride) Tablets, Glaxo Wellcome NDA 21-078 7/14/00 6/16/03 Malarone Indications: For treatment and prevention of Plasmodium falciparum malaria. Mepron (atovaquone) Suspension, Glaxo Wellcome NDA 20-500/S-005 Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline ATOVAQUONE; PROGUANIL HYDROCHLORIDE Tablet; 250MG;100MG MALARONE GLAXOSMITHKLINE 021078 ATOVAQUONE; PROGUANIL HYDROCHLORIDE Tablet; 62.5MG;25MG MALARONE PEDIATRIC GLAXOSMITHKLINE Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision

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