🇺🇸 Elimite in United States

FDA authorised Elimite on 25 August 1989 · 53 US adverse-event reports

Marketing authorisations

FDA — authorised 25 August 1989

  • Application: NDA019855
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Local brand name: ELIMITE
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

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 — 6 reports (11.32%)
  2. Headache — 6 reports (11.32%)
  3. Rash — 6 reports (11.32%)
  4. Anxiety — 5 reports (9.43%)
  5. Asthenia — 5 reports (9.43%)
  6. Diarrhoea — 5 reports (9.43%)
  7. Dizziness — 5 reports (9.43%)
  8. Nausea — 5 reports (9.43%)
  9. Pain — 5 reports (9.43%)
  10. Pruritus — 5 reports (9.43%)

Source database →

Elimite in other countries

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

Other Other approved in United States

Frequently asked questions

Is Elimite approved in United States?

Yes. FDA authorised it on 25 August 1989; FDA has authorised it.

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

AUROBINDO PHARMA USA holds the US marketing authorisation.