pramipexole dihydrochloride

FDA Drug Profile — pramipexole dihydrochloride

Drug Details

Generic Name
pramipexole dihydrochloride
Brand Names
pramipexole dihydrochloride
Application Number
ANDA202702
Sponsor
Strides Pharma Science Limited
NDC Codes
12
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
PRAMIPEXOLE DIHYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson’s disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).