Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021926
Company: CURRAX
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 |
---|---|---|---|---|---|
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 | 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 |
---|---|---|---|---|---|
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 |
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 |