← FDA DRUG APPROVALS

FDA NDA · NDA022008

REQUIP XL

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA022008
TYPE
NDA
ORIGINAL APPROVAL
2008-06-13
LATEST ACTION
2021-07-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
REQUIP XL · ReferenceDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-07-12Labeling · Supplement 13 · standard — Letter ↗AP
2021-07-12Labeling · Supplement 12 · standard — Letter ↗AP
2017-03-23Efficacy · Supplement 9 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 8 · standard — Label ↗AP
2014-08-28Labeling · Supplement 4 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 7 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 3 · standard — Label ↗AP
2009-04-10Manufacturing (CMC) · Supplement 2 — Label ↗AP
2008-10-31Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2008-06-13Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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