Application Nr Approved Date Route Status External Links
ANDA202727 2012-05-18 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. D&c Red No. 33 D&C RED NO. 33 Molecular DYE-Dye
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
5. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
6. Gelatin GELATIN Unresolved
7. Hypromelloses HYPROMELLOSES Unresolved
8. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
9. Polyethylene Glycols POLYETHYLENE GLYCOLS 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

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lansoprazole LANSOPRAZOLE ZINC599734

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