🇺🇸 Ultiva in United States

FDA authorised Ultiva on 12 July 1996 · 672 US adverse-event reports

Marketing authorisations

FDA — authorised 12 July 1996

  • Application: NDA020630
  • Marketing authorisation holder: MYLAN INSTITUTIONAL
  • 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. Anaphylactic Shock — 184 reports (27.38%)
  2. Hypotension — 77 reports (11.46%)
  3. Blood Pressure Decreased — 62 reports (9.23%)
  4. Tachycardia — 61 reports (9.08%)
  5. Cardiac Arrest — 58 reports (8.63%)
  6. Anaphylactic Reaction — 54 reports (8.04%)
  7. Bronchospasm — 49 reports (7.29%)
  8. Rash — 48 reports (7.14%)
  9. Erythema — 41 reports (6.1%)
  10. Pyrexia — 38 reports (5.65%)

Source database →

Ultiva 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 Ultiva approved in United States?

Yes. FDA authorised it on 12 July 1996; FDA has authorised it.

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

MYLAN INSTITUTIONAL holds the US marketing authorisation.