🇺🇸 Oxycodone Hydrochloride 5 Mg in United States

FDA authorised Oxycodone Hydrochloride 5 Mg on 26 October 1998 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 26 October 1998

  • Application: NDA020932
  • Marketing authorisation holder: ROXANE
  • Local brand name: ROXICODONE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 31 August 2000

  • Application: NDA021011
  • Marketing authorisation holder: SPECGX LLC
  • Local brand name: ROXICODONE
  • Indication: TABLET — ORAL
  • Status: approved

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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. Malaise — 2 reports (18.18%)
  2. Affect Lability — 1 report (9.09%)
  3. Asthenia — 1 report (9.09%)
  4. Crying — 1 report (9.09%)
  5. Death — 1 report (9.09%)
  6. Depression — 1 report (9.09%)
  7. Drug Ineffective — 1 report (9.09%)
  8. Faecalith — 1 report (9.09%)
  9. Lethargy — 1 report (9.09%)
  10. Product Substitution Issue — 1 report (9.09%)

Source database →

Oxycodone Hydrochloride 5 Mg 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 Oxycodone Hydrochloride 5 Mg approved in United States?

Yes. FDA authorised it on 26 October 1998; FDA authorised it on 31 August 2000; FDA has authorised it.

Who is the marketing authorisation holder for Oxycodone Hydrochloride 5 Mg in United States?

ROXANE holds the US marketing authorisation.