🇺🇸 "Cetaphil Healing Ointment" in United States

FDA authorised "Cetaphil Healing Ointment" on 14 December 1982 · 259,335 US adverse-event reports

Marketing authorisations

FDA — authorised 14 December 1982

  • Application: NDA018702
  • Marketing authorisation holder: FOUGERA PHARMS
  • Status: supplemented

FDA — authorised 1 November 1988

  • Application: ANDA087375
  • Marketing authorisation holder: IVAX PHARMS
  • Status: approved

FDA — authorised 1 November 1988

  • Application: ANDA087376
  • Marketing authorisation holder: IVAX PHARMS
  • Status: supplemented

FDA — authorised 1 November 1988

  • Application: ANDA087377
  • Marketing authorisation holder: IVAX PHARMS
  • Status: supplemented

FDA — authorised 28 September 2018

  • Application: ANDA207680
  • Marketing authorisation holder: PAI HOLDINGS PHARM
  • 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 — 39,075 reports (15.07%)
  2. Off Label Use — 34,767 reports (13.41%)
  3. Impaired Healing — 31,460 reports (12.13%)
  4. Fatigue — 26,210 reports (10.11%)
  5. Dyspnoea — 23,523 reports (9.07%)
  6. Pain — 23,293 reports (8.98%)
  7. Diarrhoea — 21,542 reports (8.31%)
  8. Nausea — 21,031 reports (8.11%)
  9. Headache — 19,395 reports (7.48%)
  10. Rash — 19,039 reports (7.34%)

Source database →

Other Dermatology approved in United States

Frequently asked questions

Is "Cetaphil Healing Ointment" approved in United States?

Yes. FDA authorised it on 14 December 1982; FDA authorised it on 1 November 1988; FDA authorised it on 1 November 1988.

Who is the marketing authorisation holder for "Cetaphil Healing Ointment" in United States?

FOUGERA PHARMS holds the US marketing authorisation.