🇺🇸 cardiac output changes with "nor-epinephrine" in United States

FDA authorised cardiac output changes with "nor-epinephrine" on 19 November 1948 · 64,169 US adverse-event reports

Marketing authorisations

FDA — authorised 19 November 1948

  • Application: NDA021381
  • Marketing authorisation holder: DENTSPLY PHARM
  • Status: approved

FDA — authorised 18 November 1965

  • Application: NDA021383
  • Marketing authorisation holder: DENTSPLY PHARM
  • Status: supplemented

FDA — authorised 20 December 1972

  • Application: ANDA083154
  • Marketing authorisation holder: ABBOTT
  • Status: approved

FDA — authorised 2 January 1973

  • Application: NDA017060
  • Marketing authorisation holder: TEVA BRANDED PHARM
  • Status: supplemented

FDA — authorised 7 December 2012

  • Application: NDA204200
  • Marketing authorisation holder: PH HEALTH
  • 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. Drug Ineffective — 13,084 reports (20.39%)
  2. Fatigue — 6,768 reports (10.55%)
  3. Headache — 6,684 reports (10.42%)
  4. Pain — 6,547 reports (10.2%)
  5. Nausea — 6,446 reports (10.05%)
  6. Off Label Use — 6,180 reports (9.63%)
  7. Dyspnoea — 5,923 reports (9.23%)
  8. Sinusitis — 4,309 reports (6.72%)
  9. Diarrhoea — 4,214 reports (6.57%)
  10. Dizziness — 4,014 reports (6.26%)

Source database →

cardiac output changes with "nor-epinephrine" 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 cardiac output changes with "nor-epinephrine" approved in United States?

Yes. FDA authorised it on 19 November 1948; FDA authorised it on 18 November 1965; FDA authorised it on 20 December 1972.

Who is the marketing authorisation holder for cardiac output changes with "nor-epinephrine" in United States?

DENTSPLY PHARM holds the US marketing authorisation.