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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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. Fourteen 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
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020239
Tradename Dosage Ingredient NDA Submissiondate
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2007-03-08
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2004-07-19
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2004-06-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 29, 1993TE:RLD:Yes

Profile for product number 002

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4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 003

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0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Expired US Patents for NDA 020239

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-004 Mar 11, 1994   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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