🇺🇸 PEG 3350 in United States

FDA authorised PEG 3350 on 13 July 1984 · 1,340 US adverse-event reports

Marketing authorisations

FDA — authorised 13 July 1984

  • Application: NDA019011
  • Marketing authorisation holder: AZURITY
  • Status: supplemented

FDA — authorised 22 April 1991

  • Application: NDA019797
  • Marketing authorisation holder: AZURITY
  • Status: supplemented

FDA — authorised 2 August 2006

  • Application: NDA021881
  • Marketing authorisation holder: SALIX PHARMS
  • Status: supplemented

FDA — authorised 6 October 2009

  • Application: ANDA090685
  • Marketing authorisation holder: PPI-DAC
  • Status: supplemented

FDA — authorised 25 January 2012

  • Application: ANDA090145
  • Marketing authorisation holder: NOVEL LABS INC
  • 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. Vomiting — 239 reports (17.84%)
  2. Nausea — 235 reports (17.54%)
  3. Abdominal Pain — 134 reports (10%)
  4. Abdominal Distension — 128 reports (9.55%)
  5. Pain — 114 reports (8.51%)
  6. Drug Ineffective — 108 reports (8.06%)
  7. Headache — 105 reports (7.84%)
  8. Off Label Use — 99 reports (7.39%)
  9. Constipation — 93 reports (6.94%)
  10. Pyrexia — 85 reports (6.34%)

Source database →

Other Gastroenterology approved in United States

Frequently asked questions

Is PEG 3350 approved in United States?

Yes. FDA authorised it on 13 July 1984; FDA authorised it on 22 April 1991; FDA authorised it on 2 August 2006.

Who is the marketing authorisation holder for PEG 3350 in United States?

AZURITY holds the US marketing authorisation.