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. 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. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for 022008

Tradename:	REQUIP XL
Applicant:	Glaxosmithkline Llc
Ingredient:	ropinirole hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 13, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 13, 2008	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 13, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 022008

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	5,422,123	⤷ Subscribe
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	7,927,624	⤷ Subscribe
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008	7,927,624	⤷ Subscribe
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	7,927,624	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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