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Orange Book product · Generic (ANDA)

ROPINIROLE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE

Generic (ANDA)ANDA 201047TE ABRX SANDOZ INC
View ROPINIROLE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jun 06, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 06, 2012

    14 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROPINIROLE HYDROCHLORIDE

Strength

EQ 2MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 201047

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ROPINIROLE HYDROCHLORIDE

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.

Agent CTA Background

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