Application Nr Approved Date Route Status External Links
ANDA204923 2016-11-07 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer Allows Absorption Of This Omeprazole Product

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Gelatin GELATIN Unresolved
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. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved
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. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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