ropinirole

FDA Drug Profile — ropinirole, ROPINIROLE, Ropinirole

Drug Details

Generic Name
ropinirole
Brand Names
ropinirole, ROPINIROLE, Ropinirole
Application Number
ANDA204022
Sponsor
Accord Healthcare Inc.
NDC Codes
38
Dosage Forms
TABLET, FILM COATED, TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
ROPINIROLE HYDROCHLORIDE, ROPINIROLE

Indications and Usage

1 INDICATIONS AND USAGE Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1 , 1.2 ) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).