Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020239

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NDA 020239 describes KYTRIL, which is a drug marketed by Roche and is included in three NDAs. Additional details are available on the KYTRIL profile page.

The generic ingredient in KYTRIL is granisetron hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Summary for 020239

Tradename:	KYTRIL
Applicant:	Roche
Ingredient:	granisetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 29, 1993	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 11, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 17, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 020239

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004	4,886,808	⤷ Start Trial
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994	4,886,808	⤷ Start Trial
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994	5,952,340	⤷ Start Trial
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993	6,294,548	⤷ Start Trial
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-004	Mar 11, 1994	6,294,548	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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