Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsSUBCUTANEOUSStandard

ICATIBANT ACETATE

ICATIBANT ACETATE

Standard Dose
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ICATIBANT ACETATE is listed in Drugs@FDA under application 213773 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ICATIBANT ACETATE Form and strength INJECTABLE;SUBCUTANEOUS - EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2024-06-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview ICATIBANT ACETATE is listed in Drugs@FDA under application 213773 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ICATIBANT ACETATE Form and strength INJECTABLE;SUBCUTANEOUS - EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2024-06-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.