Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020305

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NDA 020305 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 020305

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons
Approval Date:	Mar 16, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons
Approval Date:	Jun 15, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020305

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-001	Mar 16, 1995	4,886,808	⤷ Start Trial
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998	4,886,808	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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