Application Nr Approved Date Route Status External Links
ANDA203104 2014-10-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Donepezil Hydrochloride Tablets Are Indicated For The Treatment Of Dementia Of The Alzheimer’s Type. Efficacy Has Been Demonstrated In Patients With Mild, Moderate, And Severe Alzheimer’s Disease. Donepezil Hydrochloride Tablets Are Acetylcholinesterase Inhibitor Indicated For The Treatment Of Dementia Of The Alzheimer’s Type. Efficacy Has Been Demonstrated In Patients With Mild, Moderate, And Severe Alzheimer’s Disease (1.0).

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. 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.
3. Candelilla Wax CANDELILLA WAX Unresolved CTG-Component or coating GRAS-Generally recognized as safe.
4. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Donepezil Hydrochloride DONEPEZIL HYDROCHLORIDE ZINC897251

Comments