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 are twenty-six drug master file entries for this compound. Seven 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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons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	⤷ Subscribe
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998	4,886,808	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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