Application Nr Approved Date Route Status External Links
ANDA203306 2016-01-13 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Acid Reducer

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Acetone ACETONE Molecular SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
5. Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A Unresolved
6. Polyethylene Glycol 4000 POLYETHYLENE GLYCOL 4000 Unresolved
7. 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.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Alcohol ALCOHOL Molecular
10. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. Water WATER Molecular
13. Shellac SHELLAC Unresolved
14. Ammonia AMMONIA Molecular
15. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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