General MedicationsINJECTIONStandard
KALBITOR
ECALLANTIDE
Standard Dose
10MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KALBITOR is listed in Drugs@FDA under application 125277 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ECALLANTIDE Form and strength INJECTABLE; INJECTION - 10MG/ML Sponsor DYAX CORP.
Structured Monograph
Clinical summary
Approval overview KALBITOR is listed in Drugs@FDA under application 125277 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ECALLANTIDE Form and strength INJECTABLE; INJECTION - 10MG/ML Sponsor DYAX CORP. Submission history Latest submission status date: 2020-12-28 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.