Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203054

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NDA 203054 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 203054

Tradename:	IRINOTECAN HYDROCHLORIDE
Applicant:	Intas Pharms Usa
Ingredient:	irinotecan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/2ML (20MG/ML)
Approval Date:	Aug 31, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/5ML (20MG/ML)
Approval Date:	Aug 31, 2017	TE:	AP	RLD:	No

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