Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Mepron (atovaquone) Suspension, GlaxoSmithKline, Labeling Revision | Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Atovaquone and Proguanil Hydrochloride Tablets, Glenmark Generics, Ltd., Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com