Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022008

Expand all

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 2MG BASE Marketing Status: Prescription

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022008
Product Number: 001
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 4MG BASE Marketing Status: Prescription

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022008
Product Number: 003
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 6MG BASE Marketing Status: Prescription

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022008
Product Number: 006
Approval Date: Apr 10, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 8MG BASE Marketing Status: Prescription

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022008
Product Number: 004
Approval Date: Jun 13, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 12MG BASE Marketing Status: Prescription

Active Ingredient: ROPINIROLE HYDROCHLORIDE
Proprietary Name: REQUIP XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022008
Product Number: 005
Approval Date: Oct 31, 2008
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REQUIP XL (ROPINIROLE HYDROCHLORIDE)
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy 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 efficacy 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English