🇺🇸 Polysporin Ointment in United States

FDA authorised Polysporin Ointment on 16 April 1974 · 31 US adverse-event reports

Marketing authorisations

FDA — authorised 16 April 1974

  • Application: ANDA061229
  • Marketing authorisation holder: MONARCH PHARMS
  • Local brand name: POLYSPORIN
  • Indication: OINTMENT — OPHTHALMIC
  • Status: approved

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FDA

  • Application: NDA050167
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Local brand name: POLYSPORIN
  • Indication: AEROSOL — TOPICAL
  • Status: approved

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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. Oedema Peripheral — 4 reports (12.9%)
  2. Abdominal Distension — 3 reports (9.68%)
  3. Abdominal Pain — 3 reports (9.68%)
  4. Asthenia — 3 reports (9.68%)
  5. Balance Disorder — 3 reports (9.68%)
  6. Depression — 3 reports (9.68%)
  7. Diarrhoea — 3 reports (9.68%)
  8. Drug Ineffective — 3 reports (9.68%)
  9. Fall — 3 reports (9.68%)
  10. Fatigue — 3 reports (9.68%)

Source database →

Other Dermatology / Infectious Disease approved in United States

Frequently asked questions

Is Polysporin Ointment approved in United States?

Yes. FDA authorised it on 16 April 1974; FDA has authorised it.

Who is the marketing authorisation holder for Polysporin Ointment in United States?

MONARCH PHARMS holds the US marketing authorisation.