Product Details for NDA 022008
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EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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Strength: EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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
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)
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
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)
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
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)
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
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
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