🇺🇸 halobetasol in United States

FDA authorised halobetasol on 14 June 2005 · 1,281 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 2005

  • Application: ANDA077109
  • Marketing authorisation holder: COSETTE
  • Status: approved

FDA — authorised 24 April 2007

  • Application: ANDA078162
  • Marketing authorisation holder: COSETTE
  • Status: approved

FDA — authorised 6 November 2015

  • Application: NDA208183
  • Marketing authorisation holder: LACER PHARMA
  • Status: approved

FDA — authorised 6 October 2020

  • Application: ANDA213560
  • Marketing authorisation holder: QUAGEN
  • Status: approved

FDA — authorised 11 August 2023

  • Application: ANDA215266
  • Marketing authorisation holder: PADAGIS ISRAEL
  • 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. Drug Ineffective — 307 reports (23.97%)
  2. Psoriasis — 239 reports (18.66%)
  3. Rash — 130 reports (10.15%)
  4. Pruritus — 122 reports (9.52%)
  5. Product Use In Unapproved Indication — 97 reports (7.57%)
  6. Pain — 87 reports (6.79%)
  7. Diarrhoea — 78 reports (6.09%)
  8. Nausea — 75 reports (5.85%)
  9. Dermatitis Atopic — 74 reports (5.78%)
  10. Arthralgia — 72 reports (5.62%)

Source database →

Other Other approved in United States

Frequently asked questions

Is halobetasol approved in United States?

Yes. FDA authorised it on 14 June 2005; FDA authorised it on 24 April 2007; FDA authorised it on 6 November 2015.

Who is the marketing authorisation holder for halobetasol in United States?

COSETTE holds the US marketing authorisation.