Home Applications 021926 Application 021926
Type NDA
Sponsor CURRAX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TREXIMET NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE TABLET;ORAL 500MG;EQ 85MG BASE Yes Yes 002 TREXIMET NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE TABLET;ORAL 60MG;EQ 10MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021926-001 TREXIMET NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 N021926-002 TREXIMET NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021926-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021926-001 7332183 2025-10-02 U-867 Drug product N021926-001 7332183*PED 2026-04-02 Pediatric extension N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 N021926-002 7332183*PED 2026-04-02 Pediatric 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 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021926-001 TREXIMET 500MG;EQ 85MG BASE TABLET / ORAL AB RLD, RS 2008-04-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021926-002 TREXIMET 60MG;EQ 10MG BASE TABLET / ORAL RLD 2015-05-14 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 2 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-001 7332183 2025-10-02 U-867 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-001 7332183*PED 2026-04-02 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021926-002 7332183*PED 2026-04-02 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-001 7332183 2025-10-02 U-867 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-001 7332183*PED 2026-04-02 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021926-002 7332183*PED 2026-04-02 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021926-001 7332183 2025-10-02 U-867 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021926-001 7332183*PED 2026-04-02 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021926-002 7332183*PED 2026-04-02 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-001 7332183 2025-10-02 U-867 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-001 7332183*PED 2026-04-02 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021926-002 7332183*PED 2026-04-02 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-001 7332183 2025-10-02 U-867 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-001 7332183*PED 2026-04-02 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021926-002 7332183*PED 2026-04-02 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-001 7332183 2025-10-02 U-867 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-001 7332183*PED 2026-04-02 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021926-002 7332183*PED 2026-04-02 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021926-001 7332183 2025-10-02 U-867 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021926-001 7332183*PED 2026-04-02 Pediatric extension 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021926-002 7332183*PED 2026-04-02 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-001 7332183 2025-10-02 U-867 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-001 7332183*PED 2026-04-02 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021926-002 7332183*PED 2026-04-02 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021926-001 7332183 2025-10-02 U-867 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021926-001 7332183*PED 2026-04-02 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021926-002 7332183*PED 2026-04-02 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021926-001 7332183 2025-10-02 U-867 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021926-001 7332183*PED 2026-04-02 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021926-002 7332183 2025-10-02 U-1719 Drug product 2015-07-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021926-002 7332183*PED 2026-04-02 Pediatric extension 4b0b4de00fa7…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-954 TREXIMET sumatriptan succinate and naproxen sodium Rebel Distributors Corp NDA Current 42847-850 Treximet Sumatriptan Succinate and Naproxen Sodium Currax Pharmaceuticals LLC NDA Current 42847-850 Treximet Sumatriptan Succinate and Naproxen Sodium Currax Pharmaceuticals LLC NDA Current 42847-850 Treximet Sumatriptan Succinate and Naproxen Sodium Currax Pharmaceuticals LLC NDA Current 42847-850 Treximet Sumatriptan Succinate and Naproxen Sodium Currax Pharmaceuticals LLC NDA Current 44183-850 Sumatriptan Succinate and Naproxen Sodium sumatriptan succinate and naproxen sodium Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven NDA AUTHORIZED GENERIC Current 44183-850 Sumatriptan Succinate and Naproxen Sodium Sumatriptan Succinate and Naproxen Sodium Macoven NDA Current 44183-850 Sumatriptan Succinate and Naproxen Sodium sumatriptan succinate and naproxen sodium Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven NDA AUTHORIZED GENERIC Current 44183-850 Sumatriptan Succinate and Naproxen Sodium sumatriptan succinate and naproxen sodium Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven NDA AUTHORIZED GENERIC Current 65224-850 Treximet Sumatriptan Succinate and Naproxen Sodium Pernix Therapeutics NDA Current 65224-850 Treximet Sumatriptan Succinate and Naproxen Sodium Pernix Therapeutics NDA Current 65224-860 Treximet Sumatriptan Succinate and Naproxen Sodium Pernix Therapeutics NDA Current 65224-860 Treximet Sumatriptan Succinate and Naproxen Sodium Pernix Therapeutics NDA Current