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ROPINIROLE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ INC · Approved 2012-06-06

Drug application

FDA Application #

ANDA201047

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROPINIROLE HYDROCHLORIDE

Generic name

Ropinirole Hydrochloride

Active ingredients

ROPINIROLE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

SANDOZ INC

First approval

2012-06-06

Source

Authoritative

Drugs@FDA application overview

Machine

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