🇺🇸 OXAPROZIN POTASSIUM in United States

FDA authorised OXAPROZIN POTASSIUM on 17 October 2002 · 7 US adverse-event reports

Marketing authorisations

FDA — authorised 17 October 2002

  • Application: NDA020776
  • Marketing authorisation holder: PFIZER
  • Local brand name: DAYPRO ALTA
  • Indication: TABLET — ORAL
  • 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. Amnesia — 1 report (14.29%)
  2. Condition Aggravated — 1 report (14.29%)
  3. Dehydration — 1 report (14.29%)
  4. Gastric Ulcer — 1 report (14.29%)
  5. Gastritis — 1 report (14.29%)
  6. Injection Site Irritation — 1 report (14.29%)
  7. Learning Disorder — 1 report (14.29%)

Source database →

OXAPROZIN POTASSIUM in other countries

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

Frequently asked questions

Is OXAPROZIN POTASSIUM approved in United States?

Yes. FDA authorised it on 17 October 2002; FDA has authorised it.

Who is the marketing authorisation holder for OXAPROZIN POTASSIUM in United States?

PFIZER holds the US marketing authorisation.