FDA.reportPublic FDA data

Application 021926

Type
NDA
Sponsor
CURRAX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATETABLET;ORAL500MG;EQ 85MG BASEYesYes
002TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATETABLET;ORAL60MG;EQ 10MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-954TREXIMETsumatriptan succinate and naproxen sodiumRebel Distributors CorpNDACurrent
42847-850TreximetSumatriptan Succinate and Naproxen SodiumCurrax Pharmaceuticals LLCNDACurrent
42847-850TreximetSumatriptan Succinate and Naproxen SodiumCurrax Pharmaceuticals LLCNDACurrent
42847-850TreximetSumatriptan Succinate and Naproxen SodiumCurrax Pharmaceuticals LLCNDACurrent
42847-850TreximetSumatriptan Succinate and Naproxen SodiumCurrax Pharmaceuticals LLCNDACurrent
44183-850Sumatriptan Succinate and Naproxen Sodiumsumatriptan succinate and naproxen sodiumCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-850Sumatriptan Succinate and Naproxen SodiumSumatriptan Succinate and Naproxen SodiumMacovenNDACurrent
44183-850Sumatriptan Succinate and Naproxen Sodiumsumatriptan succinate and naproxen sodiumCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-850Sumatriptan Succinate and Naproxen Sodiumsumatriptan succinate and naproxen sodiumCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
65224-850TreximetSumatriptan Succinate and Naproxen SodiumPernix TherapeuticsNDACurrent
65224-850TreximetSumatriptan Succinate and Naproxen SodiumPernix TherapeuticsNDACurrent
65224-860TreximetSumatriptan Succinate and Naproxen SodiumPernix TherapeuticsNDACurrent
65224-860TreximetSumatriptan Succinate and Naproxen SodiumPernix TherapeuticsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80407SUPPL 2024-11-25
80406SUPPL 2024-11-25
80305SUPPL 2024-11-22
67358SUPPL2021-05-03
67357SUPPL2021-05-03
67356SUPPL2021-05-03
67270SUPPL2021-04-30
67269SUPPL2021-04-30
59411SUPPL2019-07-23
59400SUPPL2019-07-23
59399SUPPL2019-07-23
16585SUPPL2016-05-11
6469SUPPL2016-05-11
37892SUPPL2015-05-21
16584SUPPL2015-05-21
28861SUPPL2015-05-19
52347SUPPL2015-04-16
37891SUPPL2014-05-15
16583SUPPL2012-03-20
6468SUPPL2012-03-05
28859SUPPL2011-11-16
37890SUPPL2011-11-14
28860SUPPL2011-09-26
6467SUPPL2008-10-23
44658ORIG2008-08-29
21873ORIG2008-08-29
28858ORIG2008-04-22
51675ORIG1900-01-01
51674ORIG1900-01-01
51673ORIG1900-01-01
51671ORIG1900-01-01