FDA.reportPublic FDA data

Application 020080

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMITREXSUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)YesYes
002IMITREX STATDOSESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)YesYes
003IMITREX STATDOSESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0449IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0449IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0449IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0478IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0479IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptan succinateGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0173-0739IMITREXsumatriptanGlaxoSmithKline LLCNDACurrent
0781-3169SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3169SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3169SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3169SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3169SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3170SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3170SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3170SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3170SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3170SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3172SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3172SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3172SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3172SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3172SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3173SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3173SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3173SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3173SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3173SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3174SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3174SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3174SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
0781-3174SUMATRIPTAN SUCCINATEsumatriptan succinateSandoz IncNDACurrent
66993-083SUMATRIPTAN SUCCINATEsumatriptan succinatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-083SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-083SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-083SUMATRIPTAN SUCCINATEsumatriptan succinatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-084SUMATRIPTAN SUCCINATEsumatriptan succinatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-084SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-084SUMATRIPTANsumatriptanPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-084SUMATRIPTAN SUCCINATEsumatriptan succinatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70518-2738SUMATRIPTAN SUCCINATEsumatriptan succinateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2738SUMATRIPTAN SUCCINATEsumatriptan succinateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84431SUPPL 2025-12-17
84380SUPPL 2025-12-10
69733SUPPL2021-12-21
69728SUPPL2021-12-21
67591SUPPL2021-05-25
66849SUPPL2021-03-24
54950SUPPL2018-07-23
54919SUPPL2018-07-19
50705SUPPL2017-12-15
50699SUPPL2017-12-15
34243SUPPL2015-11-25
21125SUPPL2015-11-20
12189SUPPL2015-06-12
1997SUPPL2015-06-12
34242SUPPL2012-10-04
34241SUPPL2012-10-04
21124SUPPL2012-10-04
21123SUPPL2012-10-04
12188SUPPL2012-10-04
12187SUPPL2012-10-04
1996SUPPL2012-10-04
1995SUPPL2012-10-04
34240SUPPL2010-07-31
1994SUPPL2010-07-28
20468SUPPL2007-07-24
44043ORIG2007-01-17
21122SUPPL2006-02-08
12186SUPPL2006-02-07
21120SUPPL2004-06-07
21121SUPPL2003-08-15
41141SUPPL1997-11-20