Requip Xl

NDA 22008, held by Glaxosmithkline LLC. Ropinirole Hydrochloride.

As of Nov 13, 2026, NDA 22008 (Requip Xl), held by Glaxosmithkline LLC, was first approved by FDA on Jun 13, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2008
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Mar 23, 2017	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 13, 2008	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Letter

Products

6 strengths and forms


Requip XlEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug
Requip XlEQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug
Requip XlEQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug
Requip XlEQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug
Requip XlEQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug
Requip XlEQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ropinirole Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Jul 12, 2021	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 12, 2021	Supplement 12Labeling · Standard review	Approved	Label Letter
Mar 23, 2017	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2014	Supplement 8Labeling · Standard review	Approved	Label Letter
Aug 28, 2014	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 28, 2014	Supplement 4Labeling · Standard review	Approved	Label Letter
Aug 28, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 10, 2009	Supplement 2Manufacturing	Approved	Label Letter
Oct 31, 2008	Supplement 1Manufacturing	Approved	Label Letter
Jun 13, 2008	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Letter

Identifiers

Application: NDA 22008
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters