FDA.reportPublic FDA data

Application 020132

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASEYesYes
002IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASEYesNo
003IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0735IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0735IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0735IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0735IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0735IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0735IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0736IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0737IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
21695-154IMITREXsumatriptan succinateRebel Distributors CorpNDACurrent
68258-3008SUMATRIPTAN SUCCINATEsumatriptan succinateDispensing Solutions Inc.NDACurrent
68258-3009SUMATRIPTAN SUCCINATEsumatriptan succinateDispensing Solutions Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84432SUPPL 2025-12-17
84381SUPPL 2025-12-10
73973SUPPL 2023-04-12
66851SUPPL2021-03-24
50706SUPPL2017-12-15
50697SUPPL2017-12-15
21199SUPPL2013-11-27
34292SUPPL2013-11-26
34291SUPPL2012-03-06
21198SUPPL2012-03-05
21197SUPPL2012-03-05
34290SUPPL2010-08-19
34289SUPPL2010-08-19
34288SUPPL2010-08-19
12242SUPPL2010-08-19
21196SUPPL2010-08-16
21194SUPPL2010-08-16
2055SUPPL2010-08-16
2054SUPPL2010-08-16
20478SUPPL2007-07-24
23568ORIG2007-01-17
20479SUPPL2006-05-08
2053SUPPL2004-06-23
21195SUPPL2003-08-15