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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

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. It is available from three suppliers. 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. Thirty-three suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for NDA: 020658

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020658

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 020658

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REQUIP
ropinirole hydrochloride
TABLET;ORAL 020658 NDA GlaxoSmithKline LLC 0007-4890 0007-4890-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4890-20)
REQUIP
ropinirole hydrochloride
TABLET;ORAL 020658 NDA GlaxoSmithKline LLC 0007-4891 0007-4891-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4891-20)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020658

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-002Sep 19, 19974,824,860► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-003Sep 19, 19974,824,860► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-004Sep 19, 19974,452,808► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-001Sep 19, 19974,452,808► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-003Sep 19, 19974,452,808► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fuji
Covington
Healthtrust
Citi
Dow
US Department of Justice
QuintilesIMS
McKesson
Boehringer Ingelheim
Merck

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