🇺🇸 "Usual Care" in United States

FDA authorised "Usual Care" on 29 September 2003 · 1,064,859 US adverse-event reports

Marketing authorisations

FDA — authorised 29 September 2003

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

FDA — authorised 17 March 2017

  • Application: ANDA206941
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: approved

FDA — authorised 21 July 2017

  • Application: ANDA205291
  • Marketing authorisation holder: ONESOURCE SPECIALTY
  • Status: approved

FDA — authorised 25 October 2018

  • Application: ANDA210842
  • Marketing authorisation holder: PIRAMAL CRITICAL
  • Status: approved

FDA — authorised 3 May 2023

  • Application: ANDA215403
  • Marketing authorisation holder: INFORLIFE
  • 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 — 154,165 reports (14.48%)
  2. Fatigue — 120,927 reports (11.36%)
  3. Nausea — 120,685 reports (11.33%)
  4. Off Label Use — 118,164 reports (11.1%)
  5. Diarrhoea — 103,379 reports (9.71%)
  6. Dyspnoea — 102,761 reports (9.65%)
  7. Pain — 94,810 reports (8.9%)
  8. Headache — 89,475 reports (8.4%)
  9. Vomiting — 83,193 reports (7.81%)
  10. Dizziness — 77,300 reports (7.26%)

Source database →

Frequently asked questions

Is "Usual Care" approved in United States?

Yes. FDA authorised it on 29 September 2003; FDA authorised it on 17 March 2017; FDA authorised it on 21 July 2017.

Who is the marketing authorisation holder for "Usual Care" in United States?

PERRIGO PHARMA INTL holds the US marketing authorisation.