Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021926
Company: CURRAX
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
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
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 REMS-Modified, Labeling-Medication Guide 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 MYLAN
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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