🇺🇸 FENTANYL CITRATE in United States

FDA authorised FENTANYL CITRATE on 11 July 1984 · 15,844 US adverse-event reports

Marketing authorisations

FDA — authorised 11 July 1984

  • Application: NDA019101
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 12 January 1985

  • Application: NDA019115
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 4 November 1998

  • Application: NDA020747
  • Marketing authorisation holder: CEPHALON
  • Status: supplemented

FDA — authorised 3 May 2019

  • Application: ANDA210762
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: supplemented

FDA — authorised 1 September 2020

  • Application: ANDA212086
  • Marketing authorisation holder: FRESENIUS KABI USA
  • 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. Dependence — 3,936 reports (24.84%)
  2. Overdose — 2,451 reports (15.47%)
  3. Death — 2,071 reports (13.07%)
  4. Drug Abuse — 1,727 reports (10.9%)
  5. Toxicity To Various Agents — 1,414 reports (8.92%)
  6. Ill-Defined Disorder — 1,287 reports (8.12%)
  7. Cardiac Arrest — 885 reports (5.59%)
  8. Drug Ineffective — 735 reports (4.64%)
  9. Respiratory Arrest — 706 reports (4.46%)
  10. Drug Hypersensitivity — 632 reports (3.99%)

Source database →

FENTANYL CITRATE 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 FENTANYL CITRATE approved in United States?

Yes. FDA authorised it on 11 July 1984; FDA authorised it on 12 January 1985; FDA authorised it on 4 November 1998.

Who is the marketing authorisation holder for FENTANYL CITRATE in United States?

HIKMA holds the US marketing authorisation.