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Details for New Drug Application (NDA): 022008

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NDA 022008 describes REQUIP XL, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the REQUIP XL profile page.

The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for NDA: 022008

Tradename:
REQUIP XL
Applicant:
Glaxosmithkline Llc
Ingredient:
ropinirole hydrochloride
Patents:2
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022008

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 022008

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022008 NDA GlaxoSmithKline LLC 0007-4882 0007-4882-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4882-13)
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022008 NDA GlaxoSmithKline LLC 0007-4883 0007-4883-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4883-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:Yes
Patent:8,303,986Patent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,927,624Patent Expiration:Dec 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Jun 13, 2008TE:RLD:No
Patent:8,303,986Patent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022008

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 20085,422,123► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 20085,422,123► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 20085,422,123► subscribe
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