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Orange Book product · Generic (ANDA)

ROPINIROLE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE

Generic (ANDA)ANDA 202786TE ABRX ALEMBIC
View ROPINIROLE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 22, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 22, 2013

    13 yr 4 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 202786

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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