General MedicationsINJECTIONStandard
DYSPORT
abobotulinumtoxinA
Standard Dose
300 UNITS/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DYSPORT is listed in Drugs@FDA under application 125274 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient abobotulinumtoxinA Form and strength INJECTABLE; INJECTION - 300 UNITS/VIAL Sponsor IPSEN BIOPHARM LTD Submission history Latest submission status date: 2023-09-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview DYSPORT is listed in Drugs@FDA under application 125274 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient abobotulinumtoxinA Form and strength INJECTABLE; INJECTION - 300 UNITS/VIAL Sponsor IPSEN BIOPHARM LTD Submission history Latest submission status date: 2023-09-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.