Application Nr Approved Date Route Status External Links
NDA020667 2007-07-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Parkinson's Disease Mirapex® (pramipexole Dihydrochloride) Tablets Are Indicated For The Treatment Of The Signs And Symptoms Of Idiopathic Parkinson's Disease. The Effectiveness Of Mirapex Tablets Was Demonstrated In Randomized, Controlled Trials In Patients With Early Parkinson's Disease Who Were Not Receiving Concomitant Levodopa Therapy As Well As In Patients With Advanced Disease On Concomitant Levodopa (see Clinical Studies ). Restless Legs Syndrome Mirapex 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 Symptoms Of Rls.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE ZINC3781664

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