Details for New Drug Application (NDA): 213521

NDA 213521 describes ICATIBANT ACETATE, which is a drug marketed by Alembic, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ICATIBANT ACETATE profile page.

The generic ingredient in ICATIBANT ACETATE is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.

Summary for 213521

Tradename:	ICATIBANT ACETATE
Applicant:	Eugia Pharma
Ingredient:	icatibant acetate
Patents:	0

Pharmacology for NDA: 213521

Mechanism of Action

Bradykinin B2 Receptor Antagonists

Suppliers and Packaging for NDA: 213521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213521	ANDA	Eugia US LLC	55150-351	55150-351-01	1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213521	ANDA	Eugia US LLC	55150-351	55150-351-03	3 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Aug 14, 2023	TE:	AP	RLD:	No

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