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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 078796

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NDA 078796 describes IRINOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pharmobedient, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, and Teva Pharms Usa, and is included in twenty-six NDAs. It is available from fourteen suppliers. Additional details are available on the IRINOTECAN HYDROCHLORIDE profile page.

The generic ingredient in IRINOTECAN HYDROCHLORIDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for 078796

Tradename:	IRINOTECAN HYDROCHLORIDE
Applicant:	Hospira
Ingredient:	irinotecan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/25ML (20MG/ML)
Approval Date:	Feb 27, 2008	TE:	AP	RLD:	No

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