Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078122

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NDA 078122 describes IRINOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Adaptis, 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, Sun Pharma Global, and Teva Pharms Usa, and is included in twenty-six NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for 078122

Tradename:	IRINOTECAN HYDROCHLORIDE
Applicant:	Pliva Lachema
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:	Oct 31, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/5ML (20MG/ML)
Approval Date:	Oct 31, 2008	TE:		RLD:	No

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