🇺🇸 dehydrated alcohol in United States

FDA authorised dehydrated alcohol on 23 June 2025 · 33 US adverse-event reports

Marketing authorisations

FDA — authorised 23 June 2025

  • Application: ANDA219400
  • Marketing authorisation holder: XGEN PHARMS
  • Local brand name: DEHYDRATED ALCOHOL
  • Indication: SOLUTION — INTRA-ARTERIAL
  • Status: approved

Read official source →

FDA — authorised 23 June 2025

  • Application: ANDA217845
  • Marketing authorisation holder: ACCORD HLTHCARE
  • Local brand name: DEHYDRATED ALCOHOL
  • Indication: SOLUTION — INTRA-ARTERIAL
  • Status: approved

Read official source →

FDA — authorised 23 June 2025

  • Application: ANDA219444
  • Marketing authorisation holder: BRECKENRIDGE
  • Local brand name: DEHYDRATED ALCOHOL
  • Indication: SOLUTION — INTRA-ARTERIAL
  • Status: approved

Read official source →

FDA — authorised 9 July 2025

  • Application: ANDA219569
  • Marketing authorisation holder: INGENUS PHARMS LLC
  • Local brand name: DEHYDRATED ALCOHOL
  • Indication: SOLUTION — INTRA-ARTERIAL
  • Status: approved

Read official source →

FDA — authorised 23 October 2025

  • Application: NDA214988
  • Marketing authorisation holder: ROYAL PHARMS
  • Local brand name: DEHYDRATED ALCOHOL
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

Read official source →

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. Corneal Opacity — 4 reports (12.12%)
  2. Product Complaint — 4 reports (12.12%)
  3. Product Use In Unapproved Indication — 4 reports (12.12%)
  4. Eye Swelling — 3 reports (9.09%)
  5. Fibrosis — 3 reports (9.09%)
  6. Hypotension — 3 reports (9.09%)
  7. Impaired Healing — 3 reports (9.09%)
  8. Myocardial Infarction — 3 reports (9.09%)
  9. Ocular Hyperaemia — 3 reports (9.09%)
  10. Off Label Use — 3 reports (9.09%)

Source database →

dehydrated alcohol in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is dehydrated alcohol approved in United States?

Yes. FDA authorised it on 23 June 2025; FDA authorised it on 23 June 2025; FDA authorised it on 23 June 2025.

Who is the marketing authorisation holder for dehydrated alcohol in United States?

XGEN PHARMS holds the US marketing authorisation.