FDA.reportPublic FDA data

Application 020500

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPRONATOVAQUONESUSPENSION;ORAL750MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0547MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
0173-0665MEPRONatovaquoneGlaxoSmithKline LLCNDACurrent
66993-062AtovaquoneatovaquonePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-062AtovaquoneatovaquonePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-062AtovaquoneatovaquonePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85637SUPPL 2026-04-06
85442SUPPL 2026-03-23
59384SUPPL2019-07-19
59378SUPPL2019-07-19
57879SUPPL2019-03-04
57816SUPPL2019-02-27
50087SUPPL2017-10-18
50070SUPPL2017-10-17
12644SUPPL2015-06-10
2608SUPPL2015-06-10
12643SUPPL2013-03-05
25055SUPPL2013-03-04
34717SUPPL2008-05-12
2607SUPPL2008-05-09
41397SUPPL2004-06-09
25054SUPPL2004-06-09
12642SUPPL2004-06-09