🇺🇸 Multiple-Visit-"Antibiotic Paste" in United States

FDA authorised Multiple-Visit-"Antibiotic Paste" on 6 March 1973 · 49,190 US adverse-event reports

Marketing authorisations

FDA — authorised 6 March 1973

  • Application: ANDA083205
  • Marketing authorisation holder: COLGATE
  • Status: supplemented

FDA — authorised 17 December 1996

  • Application: NDA020511
  • Marketing authorisation holder: ULURU
  • Status: supplemented

FDA — authorised 17 February 2000

  • Application: NDA021084
  • Marketing authorisation holder: US ARMY MED RES
  • Status: supplemented

FDA — authorised 14 October 2016

  • Application: NDA208844
  • Marketing authorisation holder: BRACCO
  • Status: approved

FDA — authorised 9 December 2022

  • Application: ANDA214582
  • Marketing authorisation holder: QUAGEN
  • 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 Ineffective — 10,598 reports (21.55%)
  2. Off Label Use — 5,521 reports (11.22%)
  3. Erythema — 4,732 reports (9.62%)
  4. Nausea — 4,467 reports (9.08%)
  5. Dry Skin — 4,342 reports (8.83%)
  6. Pain — 4,217 reports (8.57%)
  7. Rash — 4,037 reports (8.21%)
  8. Fatigue — 3,845 reports (7.82%)
  9. Acne — 3,827 reports (7.78%)
  10. Pyrexia — 3,604 reports (7.33%)

Source database →

Other Infectious Disease approved in United States

Frequently asked questions

Is Multiple-Visit-"Antibiotic Paste" approved in United States?

Yes. FDA authorised it on 6 March 1973; FDA authorised it on 17 December 1996; FDA authorised it on 17 February 2000.

Who is the marketing authorisation holder for Multiple-Visit-"Antibiotic Paste" in United States?

COLGATE holds the US marketing authorisation.