Details for New Drug Application (NDA): 210118

NDA 210118 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 210118

Tradename:	ICATIBANT ACETATE
Applicant:	Teva Pharms Usa
Ingredient:	icatibant acetate
Patents:	0

Pharmacology for NDA: 210118

Mechanism of Action

Bradykinin B2 Receptor Antagonists

Suppliers and Packaging for NDA: 210118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	210118	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3066	0093-3066-34	1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	210118	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3066	0093-3066-93	3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Jul 15, 2019	TE:	AP	RLD:	No

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