Application Nr Approved Date Route Status External Links
NDA022287 2009-01-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 1.1 Healing Of Erosive Esophagitiskapidex Is Indicated For Healing Of All Grades Of Erosive Esophagitis (ee) For Up To 8 Weeks. 1.2 Maintenance Of Healed Erosive Esophagitiskapidex Is Indicated To Maintain Healing Of Ee For Up To 6 Months. 1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Diseasekapidex Is Indicated For The Treatment Of Heartburn Associated With Non-Erosive Gastroesophageal Reflux Disease (gerd) For 4 Weeks.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
2. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
6. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved
7. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dexlansoprazole DEXLANSOPRAZOLE ZINC3830986

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