Application Nr Approved Date Route Status External Links
ANDA090190 2010-10-08 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pramipexole Dihydrochloride Tablets Are Non-Ergot Dopamine Agonist Indicated For The Treatment Of •the Signs And Symptoms Of Idiopathic Parkinson’s Disease (pd) (1.1) 1.1 Parkinson's Disease Pramipexole Dihydrochloride Tablets Are Indicated For The Treatment Of The Signs And Symptoms Of Idiopathic Parkinson's Disease.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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