Application Nr Approved Date Route Status External Links
ANDA078920 2010-07-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pramipexole Dihydrochloride Tablets Are A Non-Ergot Dopamine Agonist Indicated For The Treatment Of: Parkinson's Disease (pd) (1.1) 1.1 Parkinson’s Disease Pramipexole Dihydrochloride Tablets Are Indicated For The Treatment Of 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. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
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

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