Application Nr Approved Date Route Status External Links
NDA204655 2014-03-28 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredient (in Each Capsule) Purpose (each Delayed-Release Capsule Corresponds To 22.3 Mg Esomeprazole Magnesium Trihydrate) Esomeprazole 20 Mg Acid Reducer

All Formulated Excipients (17 Total)

Name Structure Kind Function Status
1. D&c Red No. 28 D&C RED NO. 28 Molecular DYE-Dye
2. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
3. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Gelatin GELATIN Unresolved
6. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
7. Hypromelloses HYPROMELLOSES Unresolved
8. 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.
9. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER 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. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
14. Starch, Corn STARCH, CORN Unresolved
15. Fd&c Blue No. 2 FD&C BLUE NO. 2 Molecular DYE-Dye
16. Fd&c Red No. 3 FD&C RED NO. 3 Molecular DYE-Dye
17. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM ZINC4693574

Comments