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ROPINIROLE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ORBION PHARMS · Approved 2012-11-28

Drug application

FDA Application #

ANDA079229

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

ORBION PHARMS

Manufacturer

Bionpharma Inc.

First approval

2012-11-28

Source

Authoritative

Drugs@FDA application overview

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