Application Nr Approved Date Route Status External Links
ANDA203437 2015-06-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Entacapone Tablets, Usp Are Indicated As An Adjunct To Levodopa And Carbidopa To Treat End-Of-Dose “wearing-Off” In Patients With Parkinson’s Disease (see Clinical Pharmacology, Clinical Studies). Entacapone Tablets, Usp Effectiveness Has Not Been Systematically Evaluated In Patients With Parkinson’s Disease Who Do Not Experience End-Of-Dose “wearing-Off”.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
5. Lactose Monohydrate LACTOSE MONOHYDRATE 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. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Entacapone ENTACAPONE ZINC35342787

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