Generated: December 14, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020305
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, which is a drug marketed by Roche and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges. 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. Nineteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 020305
|Formulation / Manufacturing:||see details|Complete Access Available with Subscription
Summary 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1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**|
|Approval Date:||Mar 16, 1995||TE:||RLD:||Yes|
Summary 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2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**|
|Approval Date:||Jun 15, 1998||TE:||RLD:||Yes|
Expired Orange Book Patents for NDA: 020305
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