🇺🇸 morphine sulfate extended release capsules in United States

FDA authorised morphine sulfate extended release capsules on 20 March 2002 · 77 US adverse-event reports

Marketing authorisations

FDA — authorised 20 March 2002

  • Application: NDA021260
  • Marketing authorisation holder: KING PHARMS LLC
  • Local brand name: AVINZA
  • Indication: CAPSULE, EXTENDED RELEASE — 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. Drug Abuse — 51 reports (66.23%)
  2. Death — 8 reports (10.39%)
  3. Completed Suicide — 4 reports (5.19%)
  4. Intentional Drug Misuse — 4 reports (5.19%)
  5. Drug Ineffective — 3 reports (3.9%)
  6. Medication Residue Present — 3 reports (3.9%)
  7. Agitation — 1 report (1.3%)
  8. Alanine Aminotransferase Increased — 1 report (1.3%)
  9. Aspartate Aminotransferase Increased — 1 report (1.3%)
  10. Aspiration — 1 report (1.3%)

Source database →

morphine sulfate extended release capsules 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 morphine sulfate extended release capsules approved in United States?

Yes. FDA authorised it on 20 March 2002; FDA has authorised it.

Who is the marketing authorisation holder for morphine sulfate extended release capsules in United States?

KING PHARMS LLC holds the US marketing authorisation.