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ROPINIROLE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS ELIZABETH · Approved 2012-05-17

Drug application

FDA Application #

ANDA090869

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROPINIROLE HYDROCHLORIDE

Generic name

ROPINIROLE

Active ingredients

ROPINIROLE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS ELIZABETH

Manufacturer

Actavis Pharma, Inc.

First approval

2012-05-17

Source

Authoritative

Drugs@FDA application overview

Machine

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