🇺🇸 SULFADIAZINE SODIUM in United States

FDA authorised SULFADIAZINE SODIUM on 11 August 1941 · 15 US adverse-event reports

Marketing authorisations

FDA — authorised 11 August 1941

  • Application: NDA004054
  • Marketing authorisation holder: LEDERLE
  • Local brand name: SULFADIAZINE SODIUM
  • Indication: INJECTABLE — INJECTION
  • 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. Asthenia — 2 reports (13.33%)
  2. Drug Hypersensitivity — 2 reports (13.33%)
  3. Drug Ineffective — 2 reports (13.33%)
  4. Impaired Work Ability — 2 reports (13.33%)
  5. Pain — 2 reports (13.33%)
  6. Abdominal Discomfort — 1 report (6.67%)
  7. Astigmatism — 1 report (6.67%)
  8. Blister — 1 report (6.67%)
  9. Contraindicated Product Administered — 1 report (6.67%)
  10. Decreased Appetite — 1 report (6.67%)

Source database →

SULFADIAZINE SODIUM 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 SULFADIAZINE SODIUM approved in United States?

Yes. FDA authorised it on 11 August 1941; FDA has authorised it.

Who is the marketing authorisation holder for SULFADIAZINE SODIUM in United States?

LEDERLE holds the US marketing authorisation.