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

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
N021926-001TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATE500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15
N021926-002TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATE60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021926-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021926-00173321832025-10-02U-867Drug product
N021926-0017332183*PED2026-04-02Pediatric extension
N021926-00273321832025-10-02U-1719Drug product2015-07-27
N021926-0027332183*PED2026-04-02Pediatric extension

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 06:07:402026-07N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021926-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021926-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021926-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021926-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021926-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021926-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021926-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021926-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021926-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021926-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021926-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021926-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021926-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021926-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021926-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021926-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021926-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021926-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021926-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021926-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021926-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021926-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021926-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021926-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021926-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021926-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021926-001AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N021926-00173321832025-10-02U-867Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N021926-0017332183*PED2026-04-02Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N021926-00273321832025-10-02U-1719Drug product2015-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07N021926-0027332183*PED2026-04-02Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-00173321832025-10-02U-867Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-0017332183*PED2026-04-02Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-00273321832025-10-02U-1719Drug product2015-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-0027332183*PED2026-04-02Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-00173321832025-10-02U-867Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-0017332183*PED2026-04-02Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-00273321832025-10-02U-1719Drug product2015-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-0027332183*PED2026-04-02Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-00173321832025-10-02U-867Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-0017332183*PED2026-04-02Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-00273321832025-10-02U-1719Drug product2015-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-0027332183*PED2026-04-02Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-00173321832025-10-02U-867Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-0017332183*PED2026-04-02Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-00273321832025-10-02U-1719Drug product2015-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-0027332183*PED2026-04-02Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-00173321832025-10-02U-867Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-0017332183*PED2026-04-02Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-00273321832025-10-02U-1719Drug product2015-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-0027332183*PED2026-04-02Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-00173321832025-10-02U-867Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-0017332183*PED2026-04-02Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-00273321832025-10-02U-1719Drug product2015-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-0027332183*PED2026-04-02Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-00173321832025-10-02U-867Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-0017332183*PED2026-04-02Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-00273321832025-10-02U-1719Drug product2015-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-0027332183*PED2026-04-02Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-00173321832025-10-02U-867Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-0017332183*PED2026-04-02Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-00273321832025-10-02U-1719Drug product2015-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-0027332183*PED2026-04-02Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-00173321832025-10-02U-867Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-0017332183*PED2026-04-02Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-00273321832025-10-02U-1719Drug product2015-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-0027332183*PED2026-04-02Pediatric extensiond8e5a09893c0…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan Succinate and Naproxen SodiumSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5762bbe6-bddf-495c-adf8-9096f98a3a9c2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021926
application number: NDA021926
ndc (product): 44183-850
TreximetSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC42ddf376-8dc0-4236-be2a-0c6ae92ece042024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021926
application number: NDA021926
ndc (product): 42847-850

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

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