FDA.reportPublic FDA data

Application 021078

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MALARONEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL250MG;100MGYesYes
002MALARONE PEDIATRICATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL62.5MG;25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0675MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0675MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0675MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0675MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0675MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0676MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0676MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0676MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0676MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0676MALARONEatovaquone and proguanil hydrochlorideGlaxoSmithKline LLCNDACurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-522Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
50090-0687MALARONEatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDACurrent
50090-0687MALARONEatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDACurrent
50090-0688MALARONEatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDACurrent
50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2980Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-747MALARONEatovaquone and proguanil hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
63629-5531Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-5531Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-5531Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-5531Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-060Atovaquone and Proguanil HClatovaquone and proguanil hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85522SUPPL 2026-03-24
85521SUPPL 2026-03-24
57876SUPPL2019-03-04
57818SUPPL2019-02-27
14310SUPPL2013-03-01
4238SUPPL2013-03-01
26668SUPPL2009-11-09
36030SUPPL2009-01-02
4237SUPPL2008-12-29
14309SUPPL2008-06-12
26667SUPPL2008-05-09
4236SUPPL2008-01-09
41935SUPPL2006-07-10
41934SUPPL2006-07-10
21424SUPPL2006-07-10
21423SUPPL2006-07-10
36029SUPPL2005-03-03
26666SUPPL2005-03-03
14308SUPPL2005-03-03
4235SUPPL2005-03-03
14307SUPPL2004-12-03
26665SUPPL2004-12-02
26662SUPPL2004-09-07
14305SUPPL2004-09-07
36028SUPPL2003-12-08
26664SUPPL2003-12-08
36027ORIG2003-06-16
21422ORIG2003-06-16
4234ORIG2003-06-16
26663SUPPL2002-08-02
14306SUPPL2002-08-02
26661SUPPL2002-02-28