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General MedicationsSINGLE-USEStandard

ACTIVASE

ALTEPLASE

Standard Dose
50MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Label for ACTIVASE Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ACTIVASE is listed in Drugs@FDA under application 103172 (BLA).

Label for ACTIVASE Review priority: STANDARD Marketing status: Prescription Active ingredient ALTEPLASE Form and strength VIAL; SINGLE-USE - 50MG/VIAL Sponsor GENENTECH Submission history Latest submission status date: 2022-09-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview ACTIVASE is listed in Drugs@FDA under application 103172 (BLA). Label for ACTIVASE Review priority: STANDARD Marketing status: Prescription Active ingredient ALTEPLASE Form and strength VIAL; SINGLE-USE - 50MG/VIAL Sponsor GENENTECH Submission history Latest submission status date: 2022-09-01 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.