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ROPINIROLE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE · Approved 2017-02-28

Drug application

FDA Application #

ANDA204022

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROPINIROLE HYDROCHLORIDE

Generic name

ROPINIROLE

Active ingredients

ROPINIROLE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACCORD HLTHCARE

Manufacturer

Accord Healthcare Inc.

First approval

2017-02-28

Source

Authoritative

Drugs@FDA application overview

Machine

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