🇺🇸 Diluent in United States

FDA authorised Diluent on 14 June 1996 · 4,088 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 1996

  • Application: BLA020563
  • Marketing authorisation holder: LILLY
  • Status: supplemented

FDA — authorised 21 May 2002

  • Application: NDA021272
  • Marketing authorisation holder: UNITED THERAP
  • Status: supplemented

FDA — authorised 30 November 2017

  • Application: ANDA203649
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 22 May 2020

  • Application: ANDA210214
  • Marketing authorisation holder: DR REDDYS
  • 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. No Adverse Event — 1,909 reports (46.7%)
  2. Product Storage Error — 743 reports (18.18%)
  3. Expired Product Administered — 400 reports (9.78%)
  4. Incorrect Product Storage — 182 reports (4.45%)
  5. Herpes Zoster — 174 reports (4.26%)
  6. Pyrexia — 163 reports (3.99%)
  7. Dyspnoea — 155 reports (3.79%)
  8. Product Preparation Error — 127 reports (3.11%)
  9. Headache — 122 reports (2.98%)
  10. Incorrect Route Of Product Administration — 113 reports (2.76%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Diluent approved in United States?

Yes. FDA authorised it on 14 June 1996; FDA authorised it on 21 May 2002; FDA authorised it on 30 November 2017.

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

LILLY holds the US marketing authorisation.