🇺🇸 Sulfur Colloid in United States

FDA authorised Sulfur Colloid on 17 April 1978 · 70 US adverse-event reports

Marketing authorisations

FDA — authorised 17 April 1978

  • Application: NDA017858
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Status: supplemented

FDA — authorised 9 November 2023

  • Application: ANDA213516
  • Marketing authorisation holder: JUBILANT
  • Status: approved

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. Radioisotope Scan Abnormal — 12 reports (17.14%)
  2. Drug Ineffective — 10 reports (14.29%)
  3. Urticaria — 8 reports (11.43%)
  4. Nausea — 7 reports (10%)
  5. Vomiting — 7 reports (10%)
  6. Erythema — 6 reports (8.57%)
  7. Convulsion — 5 reports (7.14%)
  8. Dyspnoea — 5 reports (7.14%)
  9. Pruritus — 5 reports (7.14%)
  10. Rash — 5 reports (7.14%)

Source database →

Sulfur Colloid 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 Sulfur Colloid approved in United States?

Yes. FDA authorised it on 17 April 1978; FDA authorised it on 9 November 2023; FDA has authorised it.

Who is the marketing authorisation holder for Sulfur Colloid in United States?

SUN PHARM INDS INC holds the US marketing authorisation.