ropinirole hydrochloride

FDA Drug Profile — ROPINIROLE HYDROCHLORIDE, ropinirole hydrochloride

Drug Details

Generic Name
ropinirole hydrochloride
Brand Names
ROPINIROLE HYDROCHLORIDE, ropinirole hydrochloride
Application Number
ANDA090869
Sponsor
AvKARE
NDC Codes
32
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ROPINIROLE HYDROCHLORIDE

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).