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FDA NDA · NDA022150

FIRAZYR

icatibant acetate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022150
TYPE
NDA
ORIGINAL APPROVAL
2011-08-25
LATEST ACTION
2024-01-19
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FIRAZYR · ReferencePrescription
ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2024-01-19Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2022-04-28Labeling · Supplement 14 · standard — Letter ↗AP
2020-04-16Labeling · Supplement 13 · standard — Label ↗AP
2020-04-16Labeling · Supplement 12 · standard — Label ↗AP
2016-01-25Manufacturing (CMC) · Supplement 8 · priorityAP
2015-11-24Labeling · Supplement 7 · standard — Letter ↗AP
2015-08-10Labeling · Supplement 6 · standard — Letter ↗AP
2013-08-30Labeling · Supplement 4 · standard — Label ↗AP
2013-01-28Manufacturing (CMC) · Supplement 3 · priorityAP
2012-11-28Manufacturing (CMC) · Supplement 2 · priorityAP
2011-08-25Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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