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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022008

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REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 001
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 002
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 003
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 006
Approval Date: Apr 10, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 004
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022008
Product Number: 005
Approval Date: Oct 31, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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