Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210118
Company: TEVA PHARMS USA

Products on ANDA 210118

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 210118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210118Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2020	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210118

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