Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078953

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NDA 078953 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, Ingenus Pharms Llc, Intas Pharms Usa, 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 thirteen suppliers. Additional details are available on the IRINOTECAN HYDROCHLORIDE profile page.

The generic ingredient in IRINOTECAN HYDROCHLORIDE is irinotecan hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for 078953

Tradename:	IRINOTECAN HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	irinotecan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/2ML (20MG/ML)
Approval Date:	Apr 15, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/5ML (20MG/ML)
Approval Date:	Apr 15, 2010	TE:		RLD:	No

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