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Last Updated: July 8, 2020

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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. Twelve 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**
Approval Date:Mar 16, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**
Approval Date:Jun 15, 1998TE:RLD:Yes

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