🇺🇸 HR in United States

FDA authorised HR on 8 June 1994 · 47,158 US adverse-event reports

Marketing authorisations

FDA — authorised 8 June 1994

  • Application: NDA019872
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: approved

FDA — authorised 30 January 2003

  • Application: ANDA076050
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: supplemented

FDA — authorised 18 May 2012

  • Application: ANDA202319
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: supplemented

FDA — authorised 16 April 2019

  • Application: ANDA211544
  • Marketing authorisation holder: GRANULES
  • Status: supplemented

FDA — authorised 25 August 2021

  • Application: ANDA215486
  • Marketing authorisation holder: MARKSANS PHARMA
  • 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. Chronic Kidney Disease — 15,695 reports (33.28%)
  2. Acute Kidney Injury — 7,854 reports (16.65%)
  3. Renal Failure — 6,056 reports (12.84%)
  4. Renal Injury — 5,649 reports (11.98%)
  5. End Stage Renal Disease — 5,048 reports (10.7%)
  6. Tubulointerstitial Nephritis — 1,758 reports (3.73%)
  7. Incorrect Dose Administered — 1,615 reports (3.42%)
  8. Gastrooesophageal Reflux Disease — 1,176 reports (2.49%)
  9. Nephrogenic Anaemia — 1,172 reports (2.49%)
  10. Drug Ineffective — 1,135 reports (2.41%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is HR approved in United States?

Yes. FDA authorised it on 8 June 1994; FDA authorised it on 30 January 2003; FDA authorised it on 18 May 2012.

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

KENVUE BRANDS holds the US marketing authorisation.