Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsTOPICALGeneric

ULESFIA

BENZYL ALCOHOL

Standard Dose
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ULESFIA is listed in Drugs@FDA under application 022129 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BENZYL ALCOHOL Form and strength LOTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SHIONOGI INC Submission history Latest submission status date: 2020-04-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview ULESFIA is listed in Drugs@FDA under application 022129 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BENZYL ALCOHOL Form and strength LOTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SHIONOGI INC Submission history Latest submission status date: 2020-04-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.