Application Nr Approved Date Route Status External Links
ANDA202319 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. D&c Red No. 28 D&C RED NO. 28 Molecular DYE-Dye
2. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
3. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
4. Gelatin GELATIN Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
7. Meglumine MEGLUMINE Molecular
8. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
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. 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.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Cocoa COCOA Unresolved

Active Ingredients ( 1 Total)

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

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