🇺🇸 Sumatriptan and Naproxen sodium in United States

FDA authorised Sumatriptan and Naproxen sodium on 15 February 2018 · 23 US adverse-event reports

Marketing authorisations

FDA — authorised 15 February 2018

  • Application: ANDA207457
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Local brand name: SUMATRIPTAN AND NAPROXEN SODIUM
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 20 July 2018

  • Application: ANDA202803
  • Marketing authorisation holder: SUN PHARM
  • Local brand name: SUMATRIPTAN AND NAPROXEN SODIUM
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 4 September 2018

  • Application: ANDA090872
  • Marketing authorisation holder: RISING
  • Local brand name: SUMATRIPTAN AND NAPROXEN SODIUM
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Serotonin Syndrome — 5 reports (21.74%)
  2. Drug Ineffective For Unapproved Indication — 4 reports (17.39%)
  3. Drug Ineffective — 3 reports (13.04%)
  4. Appendicitis — 2 reports (8.7%)
  5. Drug Interaction — 2 reports (8.7%)
  6. Injection Site Pain — 2 reports (8.7%)
  7. Off Label Use — 2 reports (8.7%)
  8. Abdominal Pain — 1 report (4.35%)
  9. Accidental Exposure To Product — 1 report (4.35%)
  10. Blood Glucose Increased — 1 report (4.35%)

Source database →

Other Neurology approved in United States

Frequently asked questions

Is Sumatriptan and Naproxen sodium approved in United States?

Yes. FDA authorised it on 15 February 2018; FDA authorised it on 20 July 2018; FDA authorised it on 4 September 2018.

Who is the marketing authorisation holder for Sumatriptan and Naproxen sodium in United States?

AUROBINDO PHARMA LTD holds the US marketing authorisation.