🇺🇸 METOPROLOL TARTRATE in United States

FDA authorised METOPROLOL TARTRATE on 16 January 2004 · 32,894 US adverse-event reports

Marketing authorisations

FDA — authorised 16 January 2004

  • Application: ANDA076704
  • Marketing authorisation holder: MYLAN
  • Status: supplemented

FDA — authorised 29 April 2008

  • Application: ANDA078085
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 19 January 2012

  • Application: ANDA090654
  • Marketing authorisation holder: SUN PHARM INDS
  • Status: supplemented

FDA — authorised 27 August 2014

  • Application: ANDA204205
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 28 August 2025

  • Application: NDA218698
  • Marketing authorisation holder: XTM CONSULTING
  • Status: approved

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. Fatigue — 4,651 reports (14.14%)
  2. Diarrhoea — 3,931 reports (11.95%)
  3. Nausea — 3,818 reports (11.61%)
  4. Dyspnoea — 3,785 reports (11.51%)
  5. Dizziness — 3,035 reports (9.23%)
  6. Death — 3,000 reports (9.12%)
  7. Drug Ineffective — 2,866 reports (8.71%)
  8. Asthenia — 2,790 reports (8.48%)
  9. Pain — 2,562 reports (7.79%)
  10. Headache — 2,456 reports (7.47%)

Source database →

METOPROLOL TARTRATE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is METOPROLOL TARTRATE approved in United States?

Yes. FDA authorised it on 16 January 2004; FDA authorised it on 29 April 2008; FDA authorised it on 19 January 2012.

Who is the marketing authorisation holder for METOPROLOL TARTRATE in United States?

MYLAN holds the US marketing authorisation.