Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212081

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NDA 212081 describes ICATIBANT ACETATE, which is a drug marketed by Alembic, Caplin, Cipla, 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 eight suppliers. Additional details are available on the ICATIBANT ACETATE profile page.

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

Summary for 212081

Tradename:	ICATIBANT ACETATE
Applicant:	Nang Kuang Pharm Co
Ingredient:	icatibant acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Dec 16, 2020	TE:	AP	RLD:	No

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