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General MedicationsVIALStandard

MYOBLOC

Botulinum Toxin Type B

Standard Dose
5000IU/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MYOBLOC is listed in Drugs@FDA under application 103846 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient Botulinum Toxin Type B Form and strength VIAL - 5000IU/VIAL Sponsor ELAN PHARM Submission history Latest submission status date: 2021-03-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview MYOBLOC is listed in Drugs@FDA under application 103846 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient Botulinum Toxin Type B Form and strength VIAL - 5000IU/VIAL Sponsor ELAN PHARM Submission history Latest submission status date: 2021-03-10 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.