APPLICATION
ANDA211021
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-09
LATEST ACTION
2025-01-03
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ICATIBANT ACETATEPrescription
ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
Approval history
2025-01-03Labeling · Supplement 12 · standardAP
2023-11-28Labeling · Supplement 6 · standardAP
2020-09-25Labeling · Supplement 3 · standardAP
2020-03-09UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.