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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021078-001MALARONEATOVAQUONE; PROGUANIL HYDROCHLORIDE250MG;100MGTABLET / ORALABRLD, RS2000-07-14
N021078-002MALARONE PEDIATRICATOVAQUONE; PROGUANIL HYDROCHLORIDE62.5MG;25MGTABLET / ORALABRLD2000-07-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021078-001AB
N021078-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021078-001MALARONE250MG;100MGTABLET / ORALABRLD, RS2000-07-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021078-002MALARONE PEDIATRIC62.5MG;25MGTABLET / ORALABRLD2000-07-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021078-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021078-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021078-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021078-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021078-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021078-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021078-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021078-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021078-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021078-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021078-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021078-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021078-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021078-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021078-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021078-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021078-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021078-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021078-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021078-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021078-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021078-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021078-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021078-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021078-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021078-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021078-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021078-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021078-002AB1bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MALARONEATOVAQUONE AND PROGUANIL HYDROCHLORIDEGlaxoSmithKline LLCfc22e8d8-3bfb-4f70-a599-dd81262a48872026-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
ndc (product): 0173-0675
ndc (product): 0173-0676
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEA-S Medication Solutions593baf3d-bd9e-4a44-8f90-125aa4a7a99e2023-10-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
ndc (product): 50090-2980
Atovaquone and Proguanil HClATOVAQUONE AND PROGUANIL HYDROCHLORIDEPrasco Laboratories7069521a-c7f9-4e8d-99b8-0cb5c971e7cf2022-05-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021078
application number: NDA021078
ndc (product): 66993-060

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

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