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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020658


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NDA 020658 describes REQUIP, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. There are two patents protecting this drug and nine Paragraph IV challenges. Additional details are available on the REQUIP profile page.

The generic ingredient in REQUIP is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 020658
Tradename:REQUIP
Applicant:Glaxosmithkline Llc
Ingredient:ropinirole hydrochloride
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020658
Tradename Dosage Ingredient NDA Submissiondate
REQUIP TABLET;ORAL ropinirole hydrochloride 020658 2005-02-04
REQUIP TABLET;ORAL ropinirole hydrochloride 020658 2004-12-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020658

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Harvard Business School
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