🇺🇸 Migraine Relief in United States

FDA authorised Migraine Relief on 14 January 1998 · 41 US adverse-event reports

Marketing authorisations

FDA — authorised 14 January 1998

  • Application: NDA020802
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 26 November 2001

  • Application: ANDA075794
  • Marketing authorisation holder: PERRIGO
  • Status: supplemented

FDA — authorised 24 March 2009

  • Application: ANDA078682
  • Marketing authorisation holder: BIONPHARMA
  • Status: supplemented

FDA — authorised 23 February 2021

  • Application: ANDA214039
  • Marketing authorisation holder: GRANULES
  • Status: approved

FDA — authorised 2 February 2022

  • Application: ANDA211695
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: approved

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. Drug Ineffective — 8 reports (19.51%)
  2. Nausea — 5 reports (12.2%)
  3. Headache — 4 reports (9.76%)
  4. Incorrect Dose Administered — 4 reports (9.76%)
  5. Pneumonia — 4 reports (9.76%)
  6. Product Use In Unapproved Indication — 4 reports (9.76%)
  7. Abdominal Discomfort — 3 reports (7.32%)
  8. Drug Effective For Unapproved Indication — 3 reports (7.32%)
  9. Dry Mouth — 3 reports (7.32%)
  10. Feeling Abnormal — 3 reports (7.32%)

Source database →

Other Neurology approved in United States

Frequently asked questions

Is Migraine Relief approved in United States?

Yes. FDA authorised it on 14 January 1998; FDA authorised it on 26 November 2001; FDA authorised it on 24 March 2009.

Who is the marketing authorisation holder for Migraine Relief in United States?

HALEON US HOLDINGS holds the US marketing authorisation.