🇺🇸 Health in United States

FDA authorised Health on 29 September 2003 · 1,472 US adverse-event reports

Marketing authorisations

FDA — authorised 29 September 2003

  • Application: ANDA076011
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: approved

FDA — authorised 30 July 2009

  • Application: ANDA078104
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: supplemented

FDA — authorised 20 May 2011

  • Application: ANDA091292
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: supplemented

FDA — authorised 5 September 2018

  • Application: ANDA209837
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: approved

FDA — authorised 24 February 2020

  • Application: ANDA212971
  • Marketing authorisation holder: L PERRIGO CO
  • Status: supplemented

FDA

  • 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. Tooth Discolouration — 283 reports (19.23%)
  2. Diarrhoea — 161 reports (10.94%)
  3. Fatigue — 158 reports (10.73%)
  4. Nausea — 151 reports (10.26%)
  5. Headache — 131 reports (8.9%)
  6. Drug Ineffective — 129 reports (8.76%)
  7. Ageusia — 120 reports (8.15%)
  8. Pain — 120 reports (8.15%)
  9. Dyspnoea — 113 reports (7.68%)
  10. Dizziness — 106 reports (7.2%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Health approved in United States?

Yes. FDA authorised it on 29 September 2003; FDA authorised it on 30 July 2009; FDA authorised it on 20 May 2011.

Who is the marketing authorisation holder for Health in United States?

PERRIGO PHARMA INTL holds the US marketing authorisation.