General MedicationsINJECTIONStandard
Xeomin
incobotulinumtoxinA
Standard Dose
50 UNITS/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview Xeomin is listed in Drugs@FDA under application 125360 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient incobotulinumtoxinA Form and strength INJECTABLE;INJECTION - 50 UNITS/VIAL Sponsor MERZ PHARMS Submission history Latest submission status date: 2026-03-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview Xeomin is listed in Drugs@FDA under application 125360 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient incobotulinumtoxinA Form and strength INJECTABLE;INJECTION - 50 UNITS/VIAL Sponsor MERZ PHARMS Submission history Latest submission status date: 2026-03-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.