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 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 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INJECTABLE;INJECTION			Strength	EQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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		Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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		Strength	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-004	Mar 11, 1994	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993	⤷ Sign Up	⤷ Sign Up
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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