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Generated: May 27, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209449

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NDA 209449 describes NITYR, which is a drug marketed by Cycle Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the NITYR profile page.

The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 209449
Tradename:NITYR
Applicant:Cycle Pharms Ltd
Ingredient:nitisinone
Patents:0
Pharmacology for NDA: 209449
Mechanism of ActionHydroxyphenylpyruvate Dioxygenase Inhibitors
Cytochrome P450 2C9 Inhibitors
Suppliers and Packaging for NDA: 209449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITYR nitisinone TABLET;ORAL 209449 NDA Cycle Pharmaceuticals Ltd. 70709-000 70709-000-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) > 60 TABLET in 1 BOTTLE, PLASTIC
NITYR nitisinone TABLET;ORAL 209449 NDA Cycle Pharmaceuticals Ltd. 70709-002 70709-002-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) > 60 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 26, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 26, 2017TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 26, 2017TE:RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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Major Patent Expirations 2019 - 2020
 NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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