Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021926
Company: AZURITY

• Medication Guide

• Summary Review

Products on NDA 21926

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

Labels for NDA 021926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021926s019lbl.pdf
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