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Orange Book product · Generic (ANDA)

ROPINIROLE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE

Generic (ANDA)ANDA 200462DISCN AUROBINDO PHARMA USA
View ROPINIROLE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 15, 2012

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 15, 2012

    13 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROPINIROLE HYDROCHLORIDE

Strength

EQ 2MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 200462

Product number

001

Marketing status

DISCN

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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