Orange Book product · Brand (NDA)

REQUIP XL

ROPINIROLE HYDROCHLORIDE

Brand (NDA)NDA 022008DISCN GLAXOSMITHKLINE LLC

View ROPINIROLE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jun 13, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 13, 2008
18 yr 3 mo ago
Today

Pharmaceutical detail

Active ingredient

ROPINIROLE HYDROCHLORIDE

Strength

EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022008

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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