🇺🇸 DIAZEPAM in United States

FDA authorised DIAZEPAM on 16 December 1985 · 46,358 US adverse-event reports

Marketing authorisations

FDA — authorised 16 December 1985

  • Application: ANDA070311
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 20 December 1985

  • Application: ANDA070304
  • Marketing authorisation holder: CHARTWELL RX
  • Status: supplemented

FDA — authorised 20 December 1985

  • Application: ANDA070302
  • Marketing authorisation holder: CHARTWELL RX
  • Status: supplemented

FDA — authorised 20 December 1985

  • Application: ANDA070303
  • Marketing authorisation holder: CHARTWELL RX
  • Status: supplemented

FDA — authorised 20 December 1988

  • Application: ANDA072079
  • Marketing authorisation holder: HOSPIRA
  • 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. Toxicity To Various Agents — 8,911 reports (19.22%)
  2. Drug Abuse — 6,370 reports (13.74%)
  3. Drug Ineffective — 5,040 reports (10.87%)
  4. Nausea — 4,142 reports (8.93%)
  5. Completed Suicide — 3,991 reports (8.61%)
  6. Fatigue — 3,825 reports (8.25%)
  7. Drug Interaction — 3,791 reports (8.18%)
  8. Somnolence — 3,542 reports (7.64%)
  9. Anxiety — 3,390 reports (7.31%)
  10. Off Label Use — 3,356 reports (7.24%)

Source database →

Frequently asked questions

Is DIAZEPAM approved in United States?

Yes. FDA authorised it on 16 December 1985; FDA authorised it on 20 December 1985; FDA authorised it on 20 December 1985.

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

HIKMA holds the US marketing authorisation.