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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021926
Company: CURRAX

Medication Guide

Summary Review

Products on NDA 021926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes
TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	60MG;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2008	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s000Revisedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021926Orig1s017,s018ltr.pdf
04/28/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021926Orig1s017,s018ltr.pdf
07/22/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021926s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021926Orig1s016ltr.pdf
05/09/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021926s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021926Orig1s013ltr.pdf
05/14/2015	SUPPL-12	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021926Orig1s012ltr.pdf
05/14/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf
05/13/2014	SUPPL-10	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021926s010lbl.pdf
09/23/2011	SUPPL-6	Labeling-Medication Guide, REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s006ltr.pdf
03/01/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021926s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021926s005ltr.pdf
11/14/2011	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021926s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s002ltr.pdf
10/17/2008	SUPPL-1	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s001ltr.pdf

Labels for NDA 021926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf
04/28/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf
04/28/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf
07/22/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021926s016lbl.pdf
05/09/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021926s013lbl.pdf
05/14/2015	SUPPL-12	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf
05/14/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf
05/13/2014	SUPPL-10	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021926s010lbl.pdf
03/01/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021926s005lbl.pdf
11/14/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021926s002lbl.pdf

Therapeutic Equivalents for NDA 021926

TREXIMET

TABLET;ORAL; 500MG;EQ 85MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	No	AB	207457	AUROBINDO PHARMA LTD
SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	No	AB	090872	RISING
SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	No	AB	202803	SUN PHARM
TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET;ORAL	Prescription	Yes	AB	021926	CURRAX

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