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ROPINIROLE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC LTD · Approved 2010-03-24

Drug application

FDA Application #

ANDA090429

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

ALEMBIC LTD

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2010-03-24

Source

Authoritative

Drugs@FDA application overview

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