🇺🇸 Dulera in United States

FDA authorised Dulera on 22 June 2010 · 15,000 US adverse-event reports

Marketing authorisations

FDA — authorised 22 June 2010

  • Application: NDA022518
  • Marketing authorisation holder: ORGANON LLC
  • 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. Product Quality Issue — 3,230 reports (21.53%)
  2. No Adverse Event — 2,783 reports (18.55%)
  3. Drug Dose Omission — 2,140 reports (14.27%)
  4. Dyspnoea — 1,746 reports (11.64%)
  5. Poor Quality Device Used — 1,094 reports (7.29%)
  6. Cough — 883 reports (5.89%)
  7. Drug Ineffective — 873 reports (5.82%)
  8. Asthma — 842 reports (5.61%)
  9. Device Malfunction — 757 reports (5.05%)
  10. Fatigue — 652 reports (4.35%)

Source database →

Dulera 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 Dulera approved in United States?

Yes. FDA authorised it on 22 June 2010; FDA has authorised it.

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

ORGANON LLC holds the US marketing authorisation.