🇺🇸 Oseltamivir Phosphate For Oral Suspension in United States

FDA authorised Oseltamivir Phosphate For Oral Suspension on 31 October 2017 · 44 US adverse-event reports

Marketing authorisations

FDA — authorised 31 October 2017

  • Application: ANDA208823
  • Marketing authorisation holder: ALVOGEN
  • Status: supplemented

FDA — authorised 14 February 2023

  • Application: ANDA215538
  • Marketing authorisation holder: EPIC PHARMA LLC
  • Status: approved

FDA — authorised 2 July 2024

  • Application: ANDA217303
  • Marketing authorisation holder: PHARMOBEDIENT
  • 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. Vomiting — 10 reports (22.73%)
  2. Hallucination — 8 reports (18.18%)
  3. Abnormal Behaviour — 4 reports (9.09%)
  4. Confusional State — 4 reports (9.09%)
  5. Middle Insomnia — 4 reports (9.09%)
  6. Aggression — 3 reports (6.82%)
  7. Anxiety — 3 reports (6.82%)
  8. Crying — 3 reports (6.82%)
  9. Screaming — 3 reports (6.82%)
  10. Abdominal Pain Upper — 2 reports (4.55%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Oseltamivir Phosphate For Oral Suspension approved in United States?

Yes. FDA authorised it on 31 October 2017; FDA authorised it on 14 February 2023; FDA authorised it on 2 July 2024.

Who is the marketing authorisation holder for Oseltamivir Phosphate For Oral Suspension in United States?

ALVOGEN holds the US marketing authorisation.