Details for New Drug Application (NDA): 208317

NDA 208317 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 208317

Tradename:	ICATIBANT ACETATE
Applicant:	Fresenius Kabi Usa
Ingredient:	icatibant acetate
Patents:	0

Pharmacology for NDA: 208317

Mechanism of Action

Bradykinin B2 Receptor Antagonists

Suppliers and Packaging for NDA: 208317

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	208317	ANDA	Fresenius Kabi USA, LLC	63323-574	63323-574-86	1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)
ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	208317	ANDA	Fresenius Kabi USA, LLC	63323-574	63323-574-93	3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 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:	Jun 18, 2020	TE:	AP	RLD:	No

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