TheraRadar
Data updated: Sep 20, 2026

REQUIP XL (ropinirole hydrochloride) · GSK

CNS Approved 2008-06-13
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
18
Years on Market

Details

Status
Discontinued
First Approved
2008-06-13
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

GSK
Active Ingredient: ROPINIROLE HYDROCHLORIDE

REQUIP XL Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
60 FDA actions from 2008 to 2021 · 1 indication expansions
Jul 2021 SUPPL
Label · Labeling
FDA Letter Label
Mar 2017 SUPPL
Efficacy
FDA Letter Label
Aug 2014 SUPPL
Label · Labeling
FDA Letter Label

What REQUIP XL Treats

2 FDA approvals

Originally approved for its first indication in 2008 . Covers 2 distinct patient populations.

  • Other (2)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

REQUIP XL FDA Label Details

Track REQUIP XL with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA022008 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.