APPLICATION
ANDA210118
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-15
LATEST ACTION
2024-09-03
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
2024-09-03Manufacturing (CMC) · Supplement 6 · unknownAP
2024-07-18Labeling · Supplement 5 · standardAP
2020-09-25Labeling · Supplement 2 · 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.
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