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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213054

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NDA 213054 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 213054

Tradename:	ICATIBANT ACETATE
Applicant:	Dr Reddys
Ingredient:	icatibant acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Oct 5, 2020	TE:		RLD:	No

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