TREXIMET

021926 | Orange Book

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Filed April 15, 2008
Type New Drug Application
Case Type New Drug Application
Ingredients SUMATRIPTAN SUCCINATE and NAPROXEN SODIUM
Dosage Form / Route ORAL and TABLET
PatentExpiration
7,332,1835 months, 2 weeks from now
7,332,1835 months, 2 weeks from now
7,332,18311 months, 2 weeks from now
Last Updated: 1 day ago
Date Patent / Filing No. Patent and Drug Application Information
4/2/20267332183Expiration of Patent No 7,332,183: Has Pediatrict Exclusivity.
10/2/20257332183Expiration of Patent No 7,332,183: (U-867). (drug product)
10/2/20257332183Expiration of Patent No 7,332,183: (U-1719). (drug product)
11/21/2024SUPPL-19Labeling-Package Insert:
4/28/2021SUPPL-18Labeling-Medication Guide, Labeling-Package Insert:
4/28/2021SUPPL-17Labeling-Package Insert:
7/22/2019SUPPL-16Labeling-Package Insert:
5/9/2016SUPPL-13Labeling-Package Insert:
5/14/2015
Approval for TREXIMET, 60MG;EQ 10MG BASE
  • Reference Drug
  • Active Ingredient: NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
5/14/2015SUPPL-12Efficacy-Pediatric:
5/14/2015SUPPL-11Labeling-Package Insert:
5/13/2014SUPPL-10Manufacturing (CMC):
3/1/2012SUPPL-5Labeling-Package Insert:
11/14/2011SUPPL-2Labeling:
9/23/2011SUPPL-6REMS-Modified, Labeling-Medication Guide: Label is not available on this site.
10/17/2008SUPPL-1Manufacturing (CMC): Label is not available on this site.
4/15/2008
Approval for TREXIMET, 500MG;EQ 85MG BASE
  • Reference Drug
  • Active Ingredient: NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
4/15/2008ORIG-1Approval: Label is not available on this site.