Dyanavel Xr

Product manufactured by Tris Pharma Inc

Application Nr Approved Date Route Status External Links
NDA208147 2015-10-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Dyanavel Xr Is A Central Nervous System (cns) Stimulant Indicated For The Treatment Of Attention Deficit Hyperactivity Disorder (adhd) [see Clinical Studies ( 14 )]. Dyanavel Xr Is A Central Nervous System (cns) Stimulant Indicated For The Treatment Of Attention Deficit Hyperactivity Disorder (adhd) (1)

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. 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.
5. Povidones POVIDONES Unresolved
6. Polyvinyl Acetate POLYVINYL ACETATE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
8. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
9. Sodium Polystyrene Sulfonate SODIUM POLYSTYRENE SULFONATE Unresolved
10. Sucralose SUCRALOSE Molecular NNS-Non-nutritive sweetener REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amphetamine AMPHETAMINE ZINC6021033

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