Austedo

Product manufactured by Teva Neuroscience, Inc.

Application Nr Approved Date Route Status External Links
NDA208082 2017-04-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Austedo® Is Indicated For The Treatment Of: • Chorea Associated With Huntington’s Disease [see Clinical Studies (14.1)] • Tardive Dyskinesia In Adults [see Clinical Studies (14.2)] Austedo Is A Vesicular Monoamine Transporter 2 (vmat2) Inhibitor Indicated For The Treatment Of: •chorea Associated With Huntington’s Disease (1) •tardive Dyskinesia In Adults (1)

All Formulated Excipients (16 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Butylated Hydroxyanisole BUTYLATED HYDROXYANISOLE Molecular
5. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
6. 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.
7. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
12. Povidones POVIDONES Unresolved
13. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
14. Shellac SHELLAC Unresolved
15. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
16. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Deutetrabenazine

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