Application Nr Approved Date Route Status External Links
ANDA090429 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Parkinson’s Disease Ropinirole Tablets Are Indicated For The Treatment Of The Signs And Symptoms Of Idiopathic Parkinson’s Disease. The Effectiveness Of Ropinirole Tablets Were Demonstrated In Randomized, Controlled Trials In Patients With Early Parkinson’s Disease Who Were Not Receiving Concomitant L-Dopa Therapy As Well As In Patients With Advanced Disease On Concomitant L-Dopa (See Clinical Pharmacology: Clinical Trials). Restless Legs Syndrome Ropinirole Tablets Are Indicated For The Treatment Of Moderate-To-Severe Primary Restless Legs Syndrome (Rls). Key Diagnostic Criteria For Rls Are: An Urge To Move The Legs Usually Accompanied Or Caused By Uncomfortable And Unpleasant Leg Sensations; Symptoms Begin Or Worsen During Periods Of Rest Or Inactivity Such As Lying Or Sitting; Symptoms Are Partially Or Totally Relieved By Movement Such As Walking Or Stretching At Least As Long As The Activity Continues; And Symptoms Are Worse Or Occur Only In The Evening Or Night. Difficulty Falling Asleep May Frequently Be Associated With Moderate-To-Severe Rls.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ropinirole Hydrochloride ROPINIROLE HYDROCHLORIDE ZINC2041

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