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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022150
Company: TAKEDA PHARMS USA

Products on NDA 022150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FIRAZYR	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022150_firazyr_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022150Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022150Orig1s014ltr.pdf
04/16/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022150Orig1s012,s013ltr.pdf
04/16/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022150Orig1s012,s013ltr.pdf
01/25/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/24/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s007ltr.pdf
08/10/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s006ltr.pdf
08/30/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022150Orig1s004ltr.pdf
01/28/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/28/2012	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022150

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022150Orig1s014lbl.pdf
04/28/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022150Orig1s014lbl.pdf
04/16/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf
04/16/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf
11/24/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf
08/10/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf
08/30/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf
08/25/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf

Therapeutic Equivalents for NDA 022150

FIRAZYR

INJECTABLE;SUBCUTANEOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FIRAZYR	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AP	022150	TAKEDA PHARMS USA
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	212446	CIPLA
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	213521	EUGIA PHARMA
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	208317	FRESENIUS KABI USA
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	211021	JIANGSU HANSOH PHARM
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	212081	NANG KUANG PHARM CO
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	211501	SLAYBACK PHARMA LLC
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	210118	TEVA PHARMS USA

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