Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213521
Company: EUGIA PHARMA

Products on ANDA 213521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213521

ICATIBANT ACETATE

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