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Product Details for NDA 020658

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REQUIP (ROPINIROLE HYDROCHLORIDE)
EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020658
Product Number: 001
Approval Date: Sep 19, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (ROPINIROLE HYDROCHLORIDE)
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020658
Product Number: 002
Approval Date: Sep 19, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (ROPINIROLE HYDROCHLORIDE)
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020658
Product Number: 003
Approval Date: Sep 19, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (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EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: TABLET; 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: N020658
Product Number: 004
Approval Date: Sep 19, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (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
Dosage Form; Route of Administration: TABLET; 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: N020658
Product Number: 006
Approval Date: Jan 27, 1999
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (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
Dosage Form; Route of Administration: TABLET; 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: N020658
Product Number: 007
Approval Date: Jan 27, 1999
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
REQUIP (ROPINIROLE HYDROCHLORIDE)
EQ 5MG 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
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG 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: N020658
Product Number: 005
Approval Date: Sep 19, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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