Application Nr Approved Date Route Status External Links
ANDA207193 2017-08-18 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (16 Total)

Name Structure Kind Function Status
1. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
2. Fd&c Red No. 3 FD&C RED NO. 3 Molecular DYE-Dye
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Gelatin GELATIN Unresolved
5. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
6. Hypromelloses HYPROMELLOSES Unresolved
7. 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.
8. Meglumine MEGLUMINE Molecular
9. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
11. 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.
12. Shellac SHELLAC Unresolved
13. 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.
14. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
15. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
16. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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